Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010698831

FEI Number

3010698831

Entity Name

GWW

City/State/Country

Gaertringen Baden-Wurttemberg, DE

Establishment Address

Robert-Bosch-Strasse 14, Gaertringen Baden-Wurttemberg 71116, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GWW (Owner Number: 10046102)

Owner / Operator Contact Address

Robert-Bosch-Strasse 14, Gaertringen, DE-BW 71116, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Philips Medical Systems Philips Medical Systems Philips Medical Systems Philips Medical Systems Philips Medical Systems Philips Medical Systems Philips Medical Systems

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2017-07-19
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2014-02-03
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2014-02-03
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2014-02-03
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2014-02-03
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	Class 2	870.2060	2014-02-03
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2014-02-03
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2014-02-03
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2014-02-03
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2014-02-03
DXJ	Display, Cathode-Ray Tube, Medical	Cardiovascular	Class 2	870.2450	2014-02-03
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2014-02-03
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2014-02-03
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2014-02-03
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2017-07-19
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2014-02-03
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2014-02-03
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2014-02-03
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2014-02-03
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2014-02-03
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2014-02-03
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2014-02-03
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2014-02-03
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2014-02-03
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2014-02-03
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2014-02-03
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2014-02-03
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2014-02-03
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2014-02-03
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2014-02-03
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	Class 2	870.2060	2014-02-03

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Consulting LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

GWW

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
K771196	Hewlett-Packard Co.	MARKER GENERATOR MODULES - 21597A	1977-08-03
K813458	Cranbury Medical Labs, Inc.	FETASCAN 1000, 1000A OBSTETRICAL DATA	1982-01-28
K100420	Philips Medizin Systeme Boeblingen GmbH	PHILIPS OBTRACEVUE MODEL SW REV. G.00	2010-07-26
K173941	Philips Medizin Systeme Boeblingen GmbH	IntelliSpace Perinatal Rev.K.00	2018-09-10
K062137	Philips Medizin Systeme Boeblingen GmbH	MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30	2006-08-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-06	N/A	2	FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)
Z-0036-06	N/A	2	FETALGARD Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring)
Z-0007-2025	Philips North America	2	IntelliVue G7m Anesthesia Gas Module, Product Number 866173
Z-0030-05	General Electric Medical Systems Information Technology	2	GE CIC Central Station Monitoring Product, Versions 3.x, 4.0.5, 4.0.6
Z-0034-2011	Philips Medical Systems North America Co. Phillips	2	The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems". The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini-phone jack cable (Agispec-081Y-4 or Agispec-081-6) to connect to the rp5700 PC. Indicated for central monitoring of multiple adult, pediatric, and neonatal patients.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010698831. Last updated year: 2026. Please use registration number 3010698831 when referencing this establishment in official correspondence.