The following data is part of a premarket notification filed by Cathay Consolidated, Inc. with the FDA for Super Air 9000 Alternating Air Floatation Mattress System.
| Device ID | K970081 |
| 510k Number | K970081 |
| Device Name: | SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | CATHAY CONSOLIDATED, INC. P.O. BOX 333 Taipei, TW |
| Contact | Jean Rozint |
| Correspondent | Jean Rozint CATHAY CONSOLIDATED, INC. P.O. BOX 333 Taipei, TW |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-09 |
| Decision Date | 1997-11-07 |