Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038562397

FEI Number

3038562397

Entity Name

Respironics Medical Products (Shenzhen) Co., Ltd.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

101, 201, 301-B, Building 1, Park 1, Xin Qiao Dong Advanced Industrial Park, Hong Tian Community, Xin Qiao Sub-district, Bao An District,, Shenzhen Guangdong 518125, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

N/A

PMA Number

N/A

All Registered Proprietary Names

Patient Circuits CO2/Flow Sensor Adult CO2/Flow Sensor Pediatric CO2/Flow Sensor Neonatal Pediatric / Adult Combined CO2/Flow Sensor Series 3 Pediatric Combined CO2/Flow Sensor Series 3 Pediatric/Adult Flow Sensor Series 3 Neonatal Combined CO2/Flow Sensor Series 3 Neonatal Flow Sensor Series 3 Bronchoscopy Elbow AF531 Oro-Nasal SE Face Mask PerforMax Pediatric EE Total FFM - Leak 1 and 2 Sidestream Reusable Neb and Masks Comfort Gel Blue Nasal Mask Pediatric/Adult Airway Adapter with Mouthpiece Pediatric/Adult Airway Adapter 15mm Male/Female Adapter-Low Deadspace Neonatal/Pediatric Airway Adapter 15mm Male/Female Adapter Threshold Pep Threshold IMT ComfortGel Blue SE FFM Amara View SE FFM Amara View FFM - RIMR, RIMP ComfortFull FFM - RSZ Amara FFM - RIMR, RIMP Sleepware G3 Sleepware Alice 6 PSG Base Station LDE LDxN LDxS Alice 6 Headbox LDE LDx Alice PSG or components ECG wireset AF811 FFM ComfortGel Blue FFM OptiChamber Diamond with Lite Touch mask FloTrak CO2 Sensor Flow Sensor Sidestream Plus Pediatric Mask Sidestream Plus Adult Mask Sidestream Plus Nebulizer Dreamwear Silicone Pillows Mask AP111 EE/SE Nasal Mask Contour Deluxe/Comfort/Ptrak Nasal Mask Peak Flow Meter Asthma Check Asthma Mentor FFM PTrak FFM AF541 SE Full Face Mask AF531 Oro-Nasal EE Leak 1 Face Mask AF531 Oro-Nasal EE Leak 2 Face Mask Mouthpiece, Angled Disposable Angled Mouthpiece Reusable Mouthpiece Mouthpiece Straight Nuance and Nuance Pro Nasal Pillow Mask Wisp Youth Nasal Mask Shimmer Full Face Mask S/M/L/MW Dreamwear Full Med Frm w/HGR WhisperFlow Procedure Packs DreamWear Full Mask DreamWear Nasal Mask DreamWisp Nasal Mask PN841 Nasal Mask Wisp Pediatric Nasal Mask PN841 SE Nasal Mask Wisp Pediatric Nasal Mask SE Elbow Accessory Wisp Nasal Mask Wisp SE Nasal Mask Opti Chamber Valved Holding Chamber Bronchoscopy Elbow, Click Style Bronchoscopy elbow Performax Pediatric SE Total FFM Disposable/FEP/Invasive Circuits BiPAP Vision Sidestream Disposable Neb and Masks

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2000-07-21
BXP	Transducer, Gas Flow	Anesthesiology	Class 1	868.2885	2012-11-07
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2018-08-07
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2025-01-03
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2012-08-14
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	1999-11-01
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2010-08-02
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2012-11-07
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2007-12-07
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2007-09-14
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2007-07-05
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2010-08-03
OLZ	Automatic Event Detection Software For Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2007-12-31
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2007-12-31
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2010-08-03
NVP	Holding Chambers, Direct Patient Interface	Anesthesiology	Class 2	868.5630	2011-09-15
BZC	Calculator, Pulmonary Function Data	Anesthesiology	Class 2	868.1880	2007-12-18
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-12-07
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2022-01-11
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2007-12-31
BZH	Meter, Peak Flow, Spirometry	Anesthesiology	Class 2	868.1860	2007-12-07
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2007-12-31
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2024-09-30
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2024-09-30
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2000-10-02
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2013-04-26
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2015-06-17
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2015-11-09
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2006-09-12
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2015-03-06
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2016-05-23
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2012-11-07
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-12-07
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2011-04-12
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2012-08-14
MNT	Sv70 Ventilator	Anesthesiology	Class 2	868.5895	2007-12-31
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	1999-11-01

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
K051895	Datex-Ohmeda, Inc.	GE DATEX-OHMEDA ENGSTROM CARESTATION	2005-09-27
K082966	Covidien, Formerly Nellcor Puritan Bennett, Inc.	PB 540 VENTILATOR	2008-10-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24
Z-0036-04	VIASYS Med Systems	1	Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120
Z-0037-04	VIASYS Med Systems	1	Sideport Kit, consisting of an adjustable sideport valve and an O2 port elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83166

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038562397. Last updated year: 2026. Please use registration number 3038562397 when referencing this establishment in official correspondence.