The following data is part of a premarket notification filed by Apex Metal, Inc. with the FDA for Airtec2 Low Air Loss Therapy Bed.
| Device ID | K970364 |
| 510k Number | K970364 |
| Device Name: | AIRTEC2 LOW AIR LOSS THERAPY BED |
| Classification | Bed, Flotation Therapy, Powered |
| Applicant | APEX METAL, INC. P.O. BOX 1026 Mt. Pleasant, SC 29465 -1026 |
| Contact | Jean Rozint |
| Correspondent | Jean Rozint APEX METAL, INC. P.O. BOX 1026 Mt. Pleasant, SC 29465 -1026 |
| 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 |