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FDA 510(k)

HEARTSTART MRX, MODEL M3535A

K-Number: K031187 · 2003-08-27

ApplicantPhilips Medical Systems
Decision Date2003-08-27
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTSTART MRX, MODEL M3535A is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems. It received FDA 510(k) clearance on 2003-08-27 under 510(k) number K031187. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEARTSTART MRX, MODEL M3535A?

HEARTSTART MRX, MODEL M3535A is a medical device that received FDA 510(k) clearance on 2003-08-27. The listed applicant is Philips Medical Systems. The 510(k) number is K031187.

When did HEARTSTART MRX, MODEL M3535A receive FDA 510(k) clearance?

HEARTSTART MRX, MODEL M3535A received FDA 510(k) clearance on 2003-08-27, under 510(k) number K031187.

Who is the listed applicant for HEARTSTART MRX, MODEL M3535A?

The FDA 510(k) record lists Philips Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEARTSTART MRX, MODEL M3535A?

The FDA product code for HEARTSTART MRX, MODEL M3535A is MKJ. This falls under the Dental category.

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Other records listing Philips Medical Systems as applicant

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Related Devices (Code: MKJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131550HEART SYNCHeart Sync, Inc.K130684PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORPhilips Medical SystemsK131494HEART SYNCHeart Sync, Inc.K130454LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITORPhysio-Control, Inc.K123881HEARTSINE SAMARITAN PAD 350PHeartsine Technologies, Inc.K130153HEARSTART MRX WITH AIRWAY CONFIMRATION ASSISTPhilips Medical Systems

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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