The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Kinair, Low Air Loss Bed.
| Device ID | K843781 |
| 510k Number | K843781 |
| Device Name: | KINAIR, LOW AIR LOSS BED |
| Classification | Bed, Ac-powered Adjustable Hospital |
| Applicant | KINETIC CONCEPTS, INC. 3417 STEEN DR. San Antonio, TX 78219 |
| Contact | Robert A Wehrmeyer |
| Correspondent | Robert A Wehrmeyer KINETIC CONCEPTS, INC. 3417 STEEN DR. San Antonio, TX 78219 |
| Product Code | FNL |
| CFR Regulation Number | 880.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-26 |
| Decision Date | 1985-01-28 |