Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030677

FEI Number

1000524572

Entity Name

Philips North America LLC

City/State/Country

Bothell, WA, US

Establishment Address

22100 Bothell Everett Hwy, Bothell, WA 98021, US

Establishment Type(s)

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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P180028

All Registered Proprietary Names

M5071A Adult SMART Pads Cartridge M5070A Primary Battery M5072A Infant/Child SMART Pads Cartridge M5068A HeartStart Home Defibrillator M5066A HeartStart Onsite Defibrillator 05-10100 - Heartstream Pads to Zoll Adapter 989803150031 Pediatric Key 989803149981 and 989803149991 SMART Pads III 989803150161 Primary Battery 989803158211 and 989803158221 DP Pads M4744A Small Switched Internal Paddles, 2.8 cm M4743A Medium Switched Internal Paddles, 4.5 cm M4741A Extra Large Switched Internal Paddles ,7.5 cm M4742A Large Switched Internal Paddles, 6 cm 989803139301 Aviation FRx Battery 989803139261 SMART Pads II 861304 HeartStart FRx Defibrillator M5070A Primary Battery 989803139311 Infant/Child Key

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	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	1999-08-24
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2020-05-21
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)	Cardiovascular	Class 2	870.5300	2021-01-29
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2020-05-21

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
K203231	Philips North America, LLC	Switched Internal Paddles	2021-01-11
K200849	Remote Diagnostic Technologies, Ltd. A Philips Company	Tempus LS - Manual	2020-07-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2009	Philips Medical Systems North America Co. Phillips	2	NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
Z-0012-2011	Philips Medical Systems North America Co. Phillips	2	Essenta DR is a digital multifunctional X-ray systems, suitable for all routine radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography. It is designed for radiographic examination of the standing or seated patient or the recumbent patient in combination with a mobile X-ray table (trolley). The intended use is from direct digital imaging using the built in flat panel detector and in addition for free exposures on radiographic cassettes.
Z-0021-2011	Philips Medical Systems North America Co. Phillips	2	The BABIX holder is an accessory used with the BuckyDiagnost X-ray system. It is used to hold the baby either in a secured or immobilized standing position in front of the X-ray detector during the examination.
Z-0022-06	Philips Medical Systems North America Co. Phillips	2	Interis Allura BiPlane X-Ray System
Z-0022-2011	Philips Medical Systems North America Co. Phillips	2	The BABIX holder is an accessory used with the DigitalDiagnost X-ray system. It is used to hold the baby either in a secured or immobilized standing position in front of the X-ray detector during the examination.
Z-0034-2011	Philips Medical Systems North America Co. Phillips	2	The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems". The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini-phone jack cable (Agispec-081Y-4 or Agispec-081-6) to connect to the rp5700 PC. Indicated for central monitoring of multiple adult, pediatric, and neonatal patients.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030677. Last updated year: 2026. Please use registration number 3030677 when referencing this establishment in official correspondence.