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FDA 510(k)

PHILIPS GYROVIEW HR - RELEASE 2

K-Number: K923944 · 1993-04-27

ApplicantPhilips Medical Systems North America, Inc.
Decision Date1993-04-27
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHILIPS GYROVIEW HR - RELEASE 2 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems North America, Inc.. It received FDA 510(k) clearance on 1993-04-27 under 510(k) number K923944. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHILIPS GYROVIEW HR - RELEASE 2?

PHILIPS GYROVIEW HR - RELEASE 2 is a medical device that received FDA 510(k) clearance on 1993-04-27. The listed applicant is Philips Medical Systems North America, Inc.. The 510(k) number is K923944.

When did PHILIPS GYROVIEW HR - RELEASE 2 receive FDA 510(k) clearance?

PHILIPS GYROVIEW HR - RELEASE 2 received FDA 510(k) clearance on 1993-04-27, under 510(k) number K923944.

Who is the listed applicant for PHILIPS GYROVIEW HR - RELEASE 2?

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

What is the FDA product code for PHILIPS GYROVIEW HR - RELEASE 2?

The FDA product code for PHILIPS GYROVIEW HR - RELEASE 2 is LNH.

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Other records listing Philips Medical Systems North America, Inc. as applicant

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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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