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FDA 510(k)

FOCUS-GHB

K-Number: K871679 · 1987-07-28

ApplicantAwareness Technology, Inc.
Decision Date1987-07-28
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FOCUS-GHB is the device name listed in this FDA 510(k) record. The listed applicant is Awareness Technology, Inc.. It received FDA 510(k) clearance on 1987-07-28 under 510(k) number K871679. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOCUS-GHB?

FOCUS-GHB is a medical device that received FDA 510(k) clearance on 1987-07-28. The listed applicant is Awareness Technology, Inc.. The 510(k) number is K871679.

When did FOCUS-GHB receive FDA 510(k) clearance?

FOCUS-GHB received FDA 510(k) clearance on 1987-07-28, under 510(k) number K871679.

Who is the listed applicant for FOCUS-GHB?

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

What is the FDA product code for FOCUS-GHB?

The FDA product code for FOCUS-GHB is LCP.

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Other records listing Awareness Technology, Inc. as applicant

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Related Devices (Code: LCP)

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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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