FDA 510(k)

HYPEX

K-Number: K895274 · 1990-02-23

Decision Date1990-02-23

Product CodeBYW

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

HYPEX is the device name listed in this FDA 510(k) record. The listed applicant is Global Business, Inc.. It received FDA 510(k) clearance on 1990-02-23 under 510(k) number K895274. The device is classified under product code BYW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPEX?

HYPEX is a medical device that received FDA 510(k) clearance on 1990-02-23. The listed applicant is Global Business, Inc.. The 510(k) number is K895274.

When did HYPEX receive FDA 510(k) clearance?

HYPEX received FDA 510(k) clearance on 1990-02-23, under 510(k) number K895274.

Who is the listed applicant for HYPEX?

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

What is the FDA product code for HYPEX?

The FDA product code for HYPEX is BYW.

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Related Devices (Code: BYW)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.