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FDA 510(k)

GYROSCAN S15/ACS-II

K-Number: K920791 · 1992-11-06

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

Device Summary

GYROSCAN S15/ACS-II is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems, Inc.. It received FDA 510(k) clearance on 1992-11-06 under 510(k) number K920791. 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 GYROSCAN S15/ACS-II?

GYROSCAN S15/ACS-II is a medical device that received FDA 510(k) clearance on 1992-11-06. The listed applicant is Philips Medical Systems, Inc.. The 510(k) number is K920791.

When did GYROSCAN S15/ACS-II receive FDA 510(k) clearance?

GYROSCAN S15/ACS-II received FDA 510(k) clearance on 1992-11-06, under 510(k) number K920791.

Who is the listed applicant for GYROSCAN S15/ACS-II?

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

What is the FDA product code for GYROSCAN S15/ACS-II?

The FDA product code for GYROSCAN S15/ACS-II is LNH.

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Other records listing Philips Medical Systems, 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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