SIMPULSE

Mattress, Air Flotation, Alternating Pressure

KINETIC CONCEPTS, INC.

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

Pre-market Notification Details

• Device ID: K972549
• 510k Number: K972549
• Device Name: SIMPULSE
• Classification: Mattress, Air Flotation, Alternating Pressure
• Applicant: KINETIC CONCEPTS, INC. P.O. BOX 659508 San Antonio, TX 78265 -9508
• Contact: William H Quirk
• Correspondent: William H Quirk; KINETIC CONCEPTS, INC. P.O. BOX 659508 San Antonio, TX 78265 -9508
• Product Code: FNM
• CFR Regulation Number: 880.5550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-07-08
• Decision Date: 1997-11-18
• Summary: summary