The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Profile, A Critical Care Low Air Loss Bed.
| Device ID | K901901 |
| 510k Number | K901901 |
| Device Name: | PROFILE, A CRITICAL CARE LOW AIR LOSS BED |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | KINETIC CONCEPTS, INC. 4958 STOUT DR. San Antonio, TX 78219 |
| Contact | Robert A Wehrmeyer |
| Correspondent | Robert A Wehrmeyer 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 | 1990-04-27 |
| Decision Date | 1990-10-03 |