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FDA 510(k)

PHILIPS GYROSCAN T5 SERIES II

K-Number: K920578 · 1992-11-06

ApplicantPhilips Medical Systems North America, Inc.
Decision Date1992-11-06
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHILIPS GYROSCAN T5 SERIES II 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 1992-11-06 under 510(k) number K920578. 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 GYROSCAN T5 SERIES II?

PHILIPS GYROSCAN T5 SERIES II is a medical device that received FDA 510(k) clearance on 1992-11-06. The listed applicant is Philips Medical Systems North America, Inc.. The 510(k) number is K920578.

When did PHILIPS GYROSCAN T5 SERIES II receive FDA 510(k) clearance?

PHILIPS GYROSCAN T5 SERIES II received FDA 510(k) clearance on 1992-11-06, under 510(k) number K920578.

Who is the listed applicant for PHILIPS GYROSCAN T5 SERIES II?

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 GYROSCAN T5 SERIES II?

The FDA product code for PHILIPS GYROSCAN T5 SERIES II 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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