The following data is part of a premarket notification filed by Apex Metal, Inc. with the FDA for Hydrotec Low Air Loss Therapy Bed.
| Device ID | K970363 |
| 510k Number | K970363 |
| Device Name: | HYDROTEC LOW AIR LOSS THERAPY BED |
| Classification | Bed, Flotation Therapy, Powered |
| Applicant | APEX METAL, INC. 3039 ROSWELL ST. Los Angeles, CA 90065 |
| Product Code | IOQ |
| CFR Regulation Number | 890.5170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-31 |
| Decision Date | 1997-11-17 |