The following data is part of a premarket notification filed by Atmos Inc. with the FDA for Atmos S041 Wound.
| Device ID | K090130 |
| 510k Number | K090130 |
| Device Name: | ATMOS S041 WOUND |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | ATMOS INC. 1600 MANCHESTER WAY Corinth, TX 76210 |
| Contact | Carl Alletto |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-01-21 |
| Decision Date | 2009-04-02 |
| Summary: | summary |