The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Hazel Ii.
| Device ID | K921768 |
| 510k Number | K921768 |
| Device Name: | HAZEL II |
| Classification | Bed, Flotation Therapy, Powered |
| 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 | IOQ |
| CFR Regulation Number | 890.5170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-14 |
| Decision Date | 1992-04-29 |