Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012607778

FEI Number

3012607778

Entity Name

Philips North America LLC

City/State/Country

Woodinville, WA, US

Establishment Address

15100 Woodinville-Redmond Road NE, Bldg A, Suite 300, Woodinville, WA 98072, US

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

Expiration Date (Year)

2026

510(k) Number

K972418

PMA Number

N/A

All Registered Proprietary Names

05-10100 - Heartstream Pads to Zoll Adapter M1532A ECG Cable M1672A ECG Cable EEG Leadset - 989803180531 M1976A ECG Cable M1663A ECG Trunk Cable EEG Leadset - 989803180561 M1680A ECG Cable M1979A ECG Cable M1602A ECG Cable M1626A ECG Cable M1669A ECG Trunk Cable M1665A ECG Trunk Cable M1681A ECG Cable M1673A ECG Cable M1968A ECG Cable M1644A ECG Cable M1675A ECG Cable M1624A ECG Cable M1949A ECG Trunk Cable M1671A ECG Cable M1674A ECG Cable M1978A ECG Cable M1645A ECG Cable M1973A ECG Cable EEG Leadset - 989803180521 M1667A ECG Trunk Cable M1974A ECG Cable M1971A ECG Cable M1678A ECG Cable M2268A EEG Trunk Cable M1934A EEG Leadset CBL 5 Lead, Snap, Shld, AAMI, Chest, Rgd - 989803176171 M1668A ECG Trunk Cable EEG Leadset - 989803180541 CBL 5 Lead, Snap, Shld, AAMI, Limb, Rgd - 989803176161 M1533A ECG Cable CBL 5 Lead, Snap, Shld, IEC, Limb, Rgd - 989803176181 989803157501, DigiTrak XT Patient Cable, Long 989803157481, DigiTrak XT Patient Cable, short 989803157491, DigiTrak XT Patient Cable, Medium BTP-1000L-2-Lead Wire Adapter Flex Adapter BTP-1000A-Hybrid Patch Lead Wire Adapter OMNI-TRAK 3000 SERIES M5071A Adult SMART Pads Cartridge M5070A Primary Battery M5072A Infant/Child SMART Pads Cartridge M5068A HeartStart Home Defibrillator M5066A HeartStart Onsite Defibrillator 989803139301 Aviation FRx Battery 989803139261 SMART Pads II 861304 HeartStart FRx Defibrillator M5070A Primary Battery 989803139311 Infant/Child Key 989803150031 Pediatric Key 989803149981 and 989803149991 SMART Pads III 989803150161 Primary Battery 989803158211 and 989803158221 DP Pads 68-PCHAT, Fast Respond Kit 989803150111, Fast Response Kit, FR3 Pads Adapter 05-10000 - Heartstream Pads to QUIK-COMBO Adapter [FR2]

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	1999-08-24
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2003-11-12
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2020-04-21
NSA	Over-The-Counter Automated External Defibrillator	Cardiovascular	Class 3	870.5310	2020-04-21
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2020-05-21
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2020-05-21
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2018-08-08
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2009-02-17

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 Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0081-2022	Philips North America LLC	3	Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
Z-0003-2010	Philips Healthcare Inc.	3	HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

Similar Registrations

Registration Number	Establishment Name	Location
2112020	ZOLL Medical Corporation	DEERFIELD, WI, US
3010030355	PHYSIO-CONTROL MAASTRICHT, INC.	Maastricht Limburg, NL
3029871637	ZOLL International Holding B.V.	Elst Gelderland, NL
3015876	PHYSIO-CONTROL, INC.	Redmond, WA, US
3017422354	EMI (DONGGUAN) ASIA LIMITED	Dongguan City Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012607778. Last updated year: 2026. Please use registration number 3012607778 when referencing this establishment in official correspondence.