The following data is part of a premarket notification filed by Advanced Air Support Consultancy, Inc. with the FDA for Equi-pise 1000 Mrs.
| Device ID | K970350 |
| 510k Number | K970350 |
| Device Name: | EQUI-PISE 1000 MRS |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | ADVANCED AIR SUPPORT CONSULTANCY, INC. 18554 RANCHERO RD. Hesperia, CA 92345 |
| Contact | Leonard C Higgs |
| Correspondent | Leonard C Higgs ADVANCED AIR SUPPORT CONSULTANCY, INC. 18554 RANCHERO RD. Hesperia, CA 92345 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-30 |
| Decision Date | 1997-04-22 |