The following data is part of a premarket notification filed by Adroit Medical Systems, Inc. with the FDA for Soft Air, Model Sa 4000 And Mistral Air, Model Ma0100.
| Device ID | K073712 |
| 510k Number | K073712 |
| Device Name: | SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 |
| Classification | System, Thermal Regulating |
| Applicant | ADROIT MEDICAL SYSTEMS, INC. 1146 CARDING MACHINE RD. Loudon, TN 37774 |
| Contact | Jon R Hermanson |
| Correspondent | Jon R Hermanson ADROIT MEDICAL SYSTEMS, INC. 1146 CARDING MACHINE RD. Loudon, TN 37774 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-31 |
| Decision Date | 2008-06-06 |