Philips North America LLC

FDA Device Registration & Listing · Cambridge, MA, US · Registration 3006648320

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
3006648320
FEI Number
3006648320
Entity Name
Philips North America LLC
City/State/Country
Cambridge, MA, US
Establishment Address
222 Jacobs Street, Cambridge, MA 02141, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
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
K180734
PMA Number
N/A

All Registered Proprietary Names

SmartLinx Vitals Plus Patient Monitoring System Capsule Vitals Plus Patient Monitoring System Capsule Surveillance System SmartLinx Vitals Plus Patient Monitoring System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQA Oximeter Cardiovascular Class 2 870.2700 2022-11-07
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-11-07
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-11-07
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2022-11-07
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-11-07
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2022-11-07
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-11-07
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2022-11-07
DQA Oximeter Cardiovascular Class 2 870.2700 2022-11-07
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2022-11-07
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-11-07
DQA Oximeter Cardiovascular Class 2 870.2700 2022-11-07
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-11-07
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2022-11-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
K903523 Hewlett-Packard Co. HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE 1990-10-23
K973147 Nellcor Puritan Bennett, Inc. NPB-295 PULSE OXIMETER 1997-11-14
K231243 Guangdong Genial Technology Co., Ltd. Finger Clip Pulse Oximeter 2023-10-31
K971628 Somanetics Corp. SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) 1997-10-10
K153184 Shenzhen Caremed Medical Technology Co., Ltd. Caremed Reusable & Disposable SPO2 Sensors 2017-01-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2025 Philips North America 2
IntelliVue G7m Anesthesia Gas Module, Product Number 866173
Z-0035-2025 Philips North America 2
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
Z-0078-2022 Philips North America LLC 3
Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
Z-0079-2022 Philips North America LLC 3
Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304
Z-0080-2022 Philips North America LLC 3
Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006648320. Last updated year: 2026. Please use registration number 3006648320 when referencing this establishment in official correspondence.
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