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FDA 510(k)

PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A

K-Number: K040904 · 2004-09-16

ApplicantPhilips Medical Systems
Decision Date2004-09-16
Product CodeNSA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A 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 2004-09-16 under 510(k) number K040904. The device is classified under product code NSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A?

PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A is a medical device that received FDA 510(k) clearance on 2004-09-16. The listed applicant is Philips Medical Systems. The 510(k) number is K040904.

When did PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A receive FDA 510(k) clearance?

PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A received FDA 510(k) clearance on 2004-09-16, under 510(k) number K040904.

Who is the listed applicant for PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A?

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 PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A?

The FDA product code for PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A is NSA.

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Other records listing Philips Medical Systems as applicant

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Official Source

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

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