FDA 510(k)

HYPERFREE

K-Number: K913527 · 1992-01-21

Decision Date1992-01-21

Product CodeBYO

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

HYPERFREE is the device name listed in this FDA 510(k) record. The listed applicant is Kist Intl.. It received FDA 510(k) clearance on 1992-01-21 under 510(k) number K913527. The device is classified under product code BYO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPERFREE?

HYPERFREE is a medical device that received FDA 510(k) clearance on 1992-01-21. The listed applicant is Kist Intl.. The 510(k) number is K913527.

When did HYPERFREE receive FDA 510(k) clearance?

HYPERFREE received FDA 510(k) clearance on 1992-01-21, under 510(k) number K913527.

Who is the listed applicant for HYPERFREE?

The FDA 510(k) record lists Kist Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYPERFREE?

The FDA product code for HYPERFREE is BYO.

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Related Devices (Code: BYO)

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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.