Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001400310

FEI Number

3001400310

Entity Name

Respironics Deutschland GmbH & Co.KG

City/State/Country

Herrsching Bavaria, DE

Establishment Address

Gewerbestr. 17, Herrsching Bavaria 82211, DE

Establishment Type(s)

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

Owner / Operator

Philips Medical Systems International BV (Owner Number: 2518422)

Owner / Operator Contact Address

Veenpluis 6, Best, NL-NOTA 5684PC, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200480

PMA Number

N/A

All Registered Proprietary Names

Performax, FitLife EE Total Face Mask PC Direct Omnilab Direct Omnilab Advanced/Advanced + BiPAP autoSV Advanced System One BiPAP w/ & w/o Humidifier DreamStation BiPAP autoSV w/ & w/o Humidifier DreamStation BiPAP S/T w/ & w/o Humidifier DreamStation BiPAP AVAPS w/ & w/o Humidifier Trilogy Nurse Call Adaptor Cable Trilogy Evo Ventilator Nurse Call Rj9 Adapter Cable Open Dual Limb Active Exhalation Valve Nurse Call Adaptor Cable Alarm Open/Closed Trilogy EV300 12/24V Battery Cable w/terminals or adapter External Flow Sensor Assembly Adult/Pediatric OR Pediatric/Infant EverFlo EverFlo Quiet OPI and non-OPI Ultrafill Quiet Everflo Ultrafill Transfill Everflo/Everflo Q/L4 DreamWear Full Mask DreamWear Nasal Mask DreamWisp Nasal Mask DreamStation BiPAP Auto w/ & w/o Humidifier Dreamstation CPAP Auto w/ & w/o Humidifier REMstar Auto A-flex HT (Q-series) DreamStation CPAP w/ & w/o Humidifier Dreamstation CPAP Pro w/ & w/o Humidifier DreamStation BiPAP Pro w/ & w/o Humidifier DreamStation Go CPAP DreamStation Go Auto CPAP Dreamstation GO w/ & w/o Humidifier DreamStation CPAP Assist DirectView Data Management System Encore Anywhere A40 Heated Humidifier OMNILAB DIRECT Universal Battery Pack (UBP2) BiPAP A40 Ventilatory Support System Dreamstation 2 Advanced System Dreamstation 2 System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2010-08-03
MNS	Ventilator, Continuous, Non-Life-Supporting	Anesthesiology	Class 2	868.5895	2010-08-05
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2019-08-23
NOU	Continuous, Ventilator, Home Use	Anesthesiology	Class 2	868.5895	2019-08-23
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2007-12-18
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2015-03-06
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2015-01-27
MNT	Sv70 Ventilator	Anesthesiology	Class 2	868.5895	2012-12-18
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2020-09-14
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2020-09-14

Official Correspondent

No official correspondent registered.

US Agent Details

Tom Fallon Business: Philips Email: tom.fallon@philips.com Phone: (978) 9415572

Related Public Records

Same Entity

Philips Medical Systems International BV

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3038281851	Philips Polska Sp. z o.o.	Lodz Lodzkie, PL
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3008514395	Telcare, LLC	Linwood, PA, US
3004961434	RESPIRATORY TECHNOLOGIES, INC.	Plymouth, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24
K082979	Resmed, Ltd.	S8 ADVANCE	2009-01-02
K203126	Resmed Pty , Ltd.	S10 Kirra	2020-12-18
K033276	Resmed, Ltd.	VPAP III ST-A	2004-06-07
K051895	Datex-Ohmeda, Inc.	GE DATEX-OHMEDA ENGSTROM CARESTATION	2005-09-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
Z-0008-2015	Respironics California Inc	2	Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001400310. Last updated year: 2026. Please use registration number 3001400310 when referencing this establishment in official correspondence.