Philips Goldway (Shenzhen) Industrial Inc.

FDA Device Registration & Listing · SHENZHEN Guangdong, CN · Registration 3003687189

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
3003687189
FEI Number
3003687189
Entity Name
Philips Goldway (Shenzhen) Industrial Inc.
City/State/Country
SHENZHEN Guangdong, CN
Establishment Address
No.2 Keji North 3rd Road, Nan Shan District, SHENZHEN Guangdong 518057, CN
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Philips Medical Systems International BV (Owner Number: 1217116)
Owner / Operator Contact Address
Veenpluis 6, Best, NL-NOTA 5684PC, NL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K190624
PMA Number
N/A

All Registered Proprietary Names

EarlyVue VS30 (863380) EarlyVue VS30 Vital Signs Monitor

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2019-10-30
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2019-10-30
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-10-30
DSJ Alarm, Blood-Pressure Cardiovascular Class 2 870.1100 2019-10-30
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-10-30
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2019-10-30
DQA Oximeter Cardiovascular Class 2 870.2700 2019-10-30

Official Correspondent

No official correspondent registered.

US Agent Details

Deborah Currlin Business: Philips Email: deborah.currlin@philips.com Phone: (858) 9452753

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
K190624 Philips Medizin Systeme Boeblingen GmbH EarlyVue VS30 2019-10-27
K771977 Instrumentation Laboratory CO CARDIAC OUTPUT COMPUTER MODEL 701 1978-01-03
K142467 Abeon Medical Corporation IntelAir Nasal Airway Support System 2014-11-24
K861213 Datex Division Instrumentarium Corp. PB 254 IR - SPECTROMETER 1986-04-04
K172904 Philips Medizin Systeme Boeblingen GmbH IntelliVue Capnography Extension, IntelliVue Microstream Extension 2017-12-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0021-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003687189. Last updated year: 2026. Please use registration number 3003687189 when referencing this establishment in official correspondence.
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