Hazel II

FDA 510(k) K921768 · Kinetic Concepts, Inc.

Substantially Equivalent

510(k) numberK921768

Submission

Device name
Hazel II
Applicant
Kinetic Concepts, Inc.
San Antonio, TX, US
Received
April 14, 1992
Decision date
April 29, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IOQ – Bed, Flotation Therapy, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5170
Specialty
Physical Medicine

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Questions and answers

When was Hazel II cleared by the FDA?

Hazel II (K921768) received a 510(k) decision of Substantially Equivalent on April 29, 1992, 15 days after the submission was received.

What is the product code of K921768?

The FDA product code is IOQ – Bed, Flotation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5170.