HAZEL

Bed, Flotation Therapy, Powered

KINETIC CONCEPTS, INC.

The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Hazel.

Pre-market Notification Details

• Device ID: K912855
• 510k Number: K912855
• Device Name: HAZEL
• Classification: Bed, Flotation Therapy, Powered
• Applicant: KINETIC CONCEPTS, INC. P.O. BOX 8588 San Antonio, TX 78208
• Contact: William H Quirk
• Correspondent: William H Quirk; KINETIC CONCEPTS, INC. P.O. BOX 8588 San Antonio, TX 78208
• Product Code: IOQ
• CFR Regulation Number: 890.5170 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-06-28
• Decision Date: 1991-09-06