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FDA 510(k)

DIFFUSION PACKAGE / GYROSCAN NT

K-Number: K973658 · 1998-05-06

ApplicantPhilips Medical Systems North America, Inc.
Decision Date1998-05-06
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIFFUSION PACKAGE / GYROSCAN NT 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 1998-05-06 under 510(k) number K973658. 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 DIFFUSION PACKAGE / GYROSCAN NT?

DIFFUSION PACKAGE / GYROSCAN NT is a medical device that received FDA 510(k) clearance on 1998-05-06. The listed applicant is Philips Medical Systems North America, Inc.. The 510(k) number is K973658.

When did DIFFUSION PACKAGE / GYROSCAN NT receive FDA 510(k) clearance?

DIFFUSION PACKAGE / GYROSCAN NT received FDA 510(k) clearance on 1998-05-06, under 510(k) number K973658.

Who is the listed applicant for DIFFUSION PACKAGE / GYROSCAN NT?

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 DIFFUSION PACKAGE / GYROSCAN NT?

The FDA product code for DIFFUSION PACKAGE / GYROSCAN NT 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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