NASIFF ASSOC., INC.

FDA Device Registration & Listing · CENTRAL SQUARE, NY, US · Registration 1319390

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1319390
FEI Number
1319390
Entity Name
NASIFF ASSOC., INC.
City/State/Country
CENTRAL SQUARE, NY, US
Establishment Address
841-1 COUNTY ROUTE 37, CENTRAL SQUARE, NY 13036, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
NASIFF ASSOC., INC. (Owner Number: 9001556)
Owner / Operator Contact Address
841-1 COUNTY ROUTE 37, --, Central Square, NY 13036, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K972795
PMA Number
N/A

All Registered Proprietary Names

Cardio Card Holter Cardio Suite CARDIO-CARD Cardio NIBP

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2007-10-31
LOS N/A N/A Class N/A N/A 2026-04-23
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2007-03-01
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2007-10-31

Official Correspondent

ROGER NASIFF

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NASIFF ASSOC., INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K832250 Litton Medical Electronics SERVOMED BASIC BEDSIDE UNIT SMA 102- 1984-06-01
K801515 Abbott Medical Electronics Co. ABBY II PATIENT MONITOR OR VITAL SIGNS M 1980-07-08
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

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 1319390. Last updated year: 2026. Please use registration number 1319390 when referencing this establishment in official correspondence.
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