Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013500228

FEI Number

3013500228

Entity Name

Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.

City/State/Country

Tsimshatsui, Kowloon, HK

Establishment Address

Unit A, 27/F Railway Plaza, 39 Chatham Road South, Tsimshatsui, Kowloon 000000, HK

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Amphenol Critical Medical Technologies, LLC (Owner Number: 10053883)

Owner / Operator Contact Address

9586 Distribution Avenue, Suite F, San Diego, CA 92121, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K051873

PMA Number

N/A

All Registered Proprietary Names

None Cable CABLE ECG X2 3/5-LD PHILIPS AHA 20CM/9IN Cable SpaceLabs Kendall DL 12 Pin Adapter ECG lead, Multi and Monolead ECG lead, reusable CABLE,MULTI FUNCTION,DPLX SHLD,7.5FT Spacelabs Medical Ultraview Digital Telemetry System- Leadwire Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2021-12-14
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2025-06-26
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2023-06-19
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2018-06-01
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2018-06-01
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2018-06-01
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2018-06-01
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2018-06-01
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-06-01
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2017-06-20
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2024-05-08
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2024-05-08
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-05-08
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2024-05-08
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2024-05-08
ISN	Cable	Physical Medicine	Class 1	890.3420	2017-12-18
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2017-12-20
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2018-06-01
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2018-06-01
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2017-12-19
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2017-06-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-07-17
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2017-12-19
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2017-12-18
QAQ	Adjunctive Predictive Cardiovascular Indicator	Cardiovascular	Class 2	870.2210	2023-09-18
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-09-18
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2023-09-18
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2020-02-20
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2018-06-25
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2020-12-14
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2017-06-28
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2017-06-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-05-25
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2018-06-01
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2017-06-20
NIK	Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	Unknown	Class 3	N/A	2019-07-22
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2019-07-22
OJX	Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode	Unknown	Class 3	N/A	2019-07-22
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2019-07-22
NKE	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	Unknown	Class 3	N/A	2019-07-22
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2019-07-22
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2019-07-22
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2017-01-19
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2017-06-20
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2018-05-25
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2024-12-19
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2017-06-20
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)	Cardiovascular	Class 2	870.5300	2017-06-20
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2017-06-20
LIX	Aid, Cardiopulmonary Resuscitation	Cardiovascular	Class 2	870.5210	2017-06-20
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2018-07-30
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2023-06-07
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2017-06-20
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2017-06-20
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2023-09-08
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2023-09-08
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-09-08
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2023-09-08
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2023-09-08
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2017-12-18
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2019-08-06
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2017-12-19
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2018-06-01
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-04-07

Official Correspondent

No official correspondent registered.

US Agent Details

Lamont Rohde Business: Amphenol Critical Medical Technologies, LLC Email: lamont.rohde@amphenol-cmt.com Phone: (602) 7503539

Related Public Records

Same Entity

Amphenol Critical Medical Technologies, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013596024	Amphenol Medical Technologies (Dongguan) Co., Ltd.	Dongguan Guangdong, CN
3009746061	Integra Biotechnical, SA de CV	Tijuana Baja California, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K862544	Suzuken Co., Ltd.	KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH	1986-08-06
K802368	Marquette Electronics, Inc.	OPTION 301 PACEMAKER EVAL. MODULE MAC-1	1981-03-04
K131503	Edan Instruments, Inc.	SE-601 SERIES ELECTROCARDIOGRAPH	2014-02-25
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2022	Welch Allyn Inc Mortara	2	ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX, ELI280-DBA-AAFBD, ELI280-AAA-AAEBX, ELI280-BBA-ADFBD, ELI280-DDB-ACFAX, MLBUR280-81X, ELI280-CAA-ACEBX, ELI280-AAA-AAHBX, ELI280-DDB-BDFAX, ELI280-CAA-AAFBT, ELI280-DCD-ADFAD, ELI280-DDB-AACBX, ELI280-JXX-BDFAX, ELI280-CAA-ADCBX, ELI280-BCB-AACBD, ELI280-LDX-ADFBX, ELI280-LDX-ADCBX, ELI280-BDD-ADFAD, ELI280-BDB-AAFBD, ELI280-BDB-ACCAD, ELI280-BDB-ADFAD, ELI280-LDX-ADFBD, ELI280-DDB-AAFBD, ELI280-DCB-ACFAD, ELI280-AAA-BAFAF, MLBUR280-W1X, ELI280-DCB-AAABX, ELI280-AAA-ACAAX, ELI280-ADA-ABFBX, ELI280-BCB-AAFBD, ELI280-BCB-AAFBX, ELI280-CEA-ADFBX, ELI280-CDA-ADABX, ELI280-BDB-AAABX, ELI280-DDB-ACFBD, ELI280-DDB-BCFAX, ELI280-ADA-ADCAX, ELI280-BDB-AACBX, ELI280-BCB-ACAAX, BUR280-81X, ELI280-DCB-AAFBG, ELI280-BDB-AAFBT, ELI280-DCB-AAFAD, ELI280-CAA-ADFBX, ELI280-BDB-AAFBG, ELI280-BDB-AAFBX, ELI280-DCA-ACAAX, ELI280-CAB-ACFBX, ELI280-ADA-ACFAX, ELI280-CAA-AAFAT, ELI280-CAA-ACFBD, ELI280-CDA-ADCBX, ELI280-AAA-ADCBX, ELI280-CAA-AAFBD, ELI280-DCB-BAFBT, ELI280-BBA-AAAAX, ELI280-BBA-AAFAD, ELI280-DBA-AAFAD, ELI280-DCB-AAFBT, ELI280-DBA-ADFAX, ELI280-BBA-AAFBD, MLBUR280-C1X, ELI280-BBA-ADFAX, ELI280-DDD-ADFAD, ELI280-DBA-AAFAX, MLBUR280-W1D, ELI280-BCB-AACBX, ELI280-DCB-AACBD, ELI280-LDX-ADFBG, ELI280-DCB-AACBX, ELI280-DBA-ADFBD, ELI280-DDB-AAFBG, ELI280-DBA-AAABD, ELI280-DCB-AAFBX, ELI280-AAA-AAFBT, MLBUR280-C1D, ELI280-AAB-ADAAX, ELI280-DDB-AAFBT, ELI280-CAA-AACBX, ELI280-CEB-ACFBX, ELI280-CAA-ABFAX, ELI280-DDB-AAFBX, ELI280-DBA-AAAAX, ELI280-BCB-AAFBG, ELI280-BFA-ADCBX, ELI280-LDX-ADABX, MLBUR280-81D, ELI280-BBA-ADFAD, ELI280-CAA-ADHAX, ELI280-CEB-ACFBD, ELI280-AAB-ADCAD, ELI280-BDB-AACBD, ELI280-LDX-ADCBD, ELI280-AAB-ACCBX, ELI280-AAA-ABFBX, ELI280-DAB-ADCAD, ELI280-AFB-ABCBX, ELI280-DCB-AACAX, ELI280-DEB-ACFBD, ELI280-ADA-ACAAX, ELI280-AAB-ADFAD, ELI280-DCB-AAFBD, ELI280-CAA-AAAAX, ELI280-BDB-ACCAX, ELI280-CAA-AAFBX, ELI280-DDB-AAABX, ELI280-DCB-ACAAX, ELI280-CAA-ADFBD, ELI280-CBB-ACCBX, ELI280-DDB-AACBD, ELI280-DDB-ACCAX, ELI280-A, ELI280-DFA-ADCBX, ELI280-BCA-AAAAX, ELI280-DDB-AAAAX, ELI280-E, ELI280-C, ELI280-AAA-AAFBD, ELI280-DFC-ADFAD, BUR280-C1X, ELI280-D, ELI280-BAA-ACCBD, ELI280-AAA-AAAAX, BUR280-W1X, ELI280-B, ELI280-BCB-AAABX, ELI280-BCB-AACAX, BUR280-W1D, ELI280-F, ELI280-BCB-AAFAD, ELI280-BCB-BAFAX, BUR280-81D
Z-0041-2012	Edan Instruments, Inc. 7/F, Yuehai Office Bldg. 1128 Nanyou Road Nanshan, Shenzhen Guangdong China	2	ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601 series Smart Electrocardiograph ECG cable is an accessory of the following machines: SE-1 series, SE-3 series and SE-601 series electrocardiograph (ECG). The EDAN ECG is a diagnostic and prescription device only intended to be used in hospitals or healthcare facilities by qualified doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help medical professionals to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. ECG cable is packed in plastic bag, as an accessory putting together with ECG machine in the package box.
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013500228. Last updated year: 2026. Please use registration number 3013500228 when referencing this establishment in official correspondence.