Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021559257

FEI Number

3021559257

Entity Name

CAF MEDICAL SOLUTIONS INC

City/State/Country

Hockley, TX, US

Establishment Address

17539 Roberts Road, Hockley, TX 77447, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CAF Medical Solutions Inc (Owner Number: 10084159)

Owner / Operator Contact Address

17539 Roberts Road, Hockley, TX 77447, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LED-P Light, surgical, Floor standing (500mm) L-NI6 Neonatal incubator L-NI8 Neonatal incubator L3 Defibrillator monitor L5 Defibrillator Monitor Modular patient monitor. LMPLUS-12, LMPLUS-15, LMPLUS-17 LAM-8 Anesthesia machine LAM-7 Anesthesia machine LAM-6 Anesthesia Machine Electrocardiograph LQ-3 Operating Table LQ-5 Operating Table BED, HYDRAULIC, ADJUSTABLE HOSPITAL LED-50D Lamp, operating room, double ceiling type (500mm) LED-70D Lamp, operating room, double ceiling type (700mm) LED MIX-Lamp. operating room, double ceiling type (500mm/700mm) Multiparameter patient monitor LM-8, LM-10, LM-12, LM-15 L-IW B Infant Radiant Warmer L-IW Infant Radiant Warmer LI-EB- Bed AC-powered adjustable hospital

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSS	Light, Surgical, Floor Standing	General, Plastic Surgery	Class 2	878.4580	2022-02-25
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2024-05-11
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2024-05-11
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2022-09-02
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2022-09-02
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2022-09-02
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-09-02
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2022-09-02
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2022-09-02
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-09-02
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-09-02
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2022-09-02
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2022-09-02
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-09-02
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2022-09-02
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-09-02
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-09-02
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2022-09-02
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2022-09-02
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-09-02
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2022-09-02
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2022-09-02
DST	Clip, Vena-Cava	Cardiovascular	Class 2	870.3260	2022-09-02
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2022-09-02
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2024-05-11
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2022-03-29
GDC	Table, Operating-Room, Electrical	General, Plastic Surgery	Class 1	878.4960	2024-05-11
FNK	Bed, Hydraulic, Adjustable Hospital	General Hospital	Class 1	880.5110	2022-02-25
FQP	Lamp, Operating-Room	General, Plastic Surgery	Class 2	878.4580	2022-02-25
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2022-09-02
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2022-09-02
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2022-09-02
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-09-02
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-09-02
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-09-02
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2022-09-02
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2022-09-02
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2022-09-02
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-09-02
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2022-09-02
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2022-09-02
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-09-02
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-09-02
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2022-09-02
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2022-09-02
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2022-09-02
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2022-09-02
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-09-02
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2022-09-02
DST	Clip, Vena-Cava	Cardiovascular	Class 2	870.3260	2022-09-02
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2024-05-11
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2022-02-25

Official Correspondent

Oscar Arriaga

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CAF Medical Solutions 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
K943360	Ohmeda Medical	OHIO CARE PLUS INCUBATOR	1994-09-29
K771977	Instrumentation Laboratory CO	CARDIAC OUTPUT COMPUTER MODEL 701	1978-01-03
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-0041-2020	Ohmeda Medical	2	Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
Z-0003-2010	Philips Healthcare Inc.	3	HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
Z-0004-06	Medtronic Emergency Response Systems, Inc.	3	Hard shell carry case for the LIFEPAK 500 AED.
Z-0004-2017	Leonhard Lang Medizintechnik GmbH Archenweg 56 Innsbruck Austria	3	Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.
Z-0005-06	Medtronic Emergency Response Systems, Inc.	3	Hard shell carry case for the LIFEPAK CR Plus.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021559257. Last updated year: 2026. Please use registration number 3021559257 when referencing this establishment in official correspondence.