The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Kt Air Bed.
Device ID | K970468 |
510k Number | K970468 |
Device Name: | KT AIR BED |
Classification | Mattress, Air Flotation, Alternating Pressure |
Applicant | KINETIC CONCEPTS, INC. 4958 STOUT DR. San Antonio, TX 78219 |
Contact | William H Quirk |
Correspondent | William H Quirk KINETIC CONCEPTS, INC. 4958 STOUT DR. San Antonio, TX 78219 |
Product Code | FNM |
CFR Regulation Number | 880.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-02-07 |
Decision Date | 1997-09-05 |
Summary: | summary |