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FDA 510(k)

PHILIPS GYROSCAN INTERA (*)

K-Number: K992533 · 1999-10-18

ApplicantPhilips Medical Systems North America, Inc.
Decision Date1999-10-18
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHILIPS GYROSCAN INTERA (*) 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 1999-10-18 under 510(k) number K992533. 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 INTERA (*)?

PHILIPS GYROSCAN INTERA (*) is a medical device that received FDA 510(k) clearance on 1999-10-18. The listed applicant is Philips Medical Systems North America, Inc.. The 510(k) number is K992533.

When did PHILIPS GYROSCAN INTERA (*) receive FDA 510(k) clearance?

PHILIPS GYROSCAN INTERA (*) received FDA 510(k) clearance on 1999-10-18, under 510(k) number K992533.

Who is the listed applicant for PHILIPS GYROSCAN INTERA (*)?

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 INTERA (*)?

The FDA product code for PHILIPS GYROSCAN INTERA (*) 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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