The following data is part of a premarket notification filed by Apex Metal, Inc. with the FDA for Care Tec Portable Low Air Loss Therapy System.
| Device ID | K970362 |
| 510k Number | K970362 |
| Device Name: | CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | APEX METAL, INC. 3039 ROSWELL ST. Los Angeles, CA 90065 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-31 |
| Decision Date | 1997-05-16 |