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FDA 510(k)

HAZEL II

K-Number: K921768 · 1992-04-29

ApplicantKinetic Concepts, Inc.
Decision Date1992-04-29
Product CodeIOQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HAZEL II is the device name listed in this FDA 510(k) record. The listed applicant is Kinetic Concepts, Inc.. It received FDA 510(k) clearance on 1992-04-29 under 510(k) number K921768. The device is classified under product code IOQ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAZEL II?

HAZEL II is a medical device that received FDA 510(k) clearance on 1992-04-29. The listed applicant is Kinetic Concepts, Inc.. The 510(k) number is K921768.

When did HAZEL II receive FDA 510(k) clearance?

HAZEL II received FDA 510(k) clearance on 1992-04-29, under 510(k) number K921768.

Who is the listed applicant for HAZEL II?

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

What is the FDA product code for HAZEL II?

The FDA product code for HAZEL II is IOQ.

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Related Devices (Code: IOQ)

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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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