The following data is part of a premarket notification filed by Atmos Inc. with the FDA for Atmos C361/c451 Suction Pump.
| Device ID | K090445 |
| 510k Number | K090445 |
| Device Name: | ATMOS C361/C451 SUCTION PUMP |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | ATMOS INC. 3717 HUCKLEBERRY ROAD Allentown, PA 18104 |
| Contact | Marco Schlegel |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-02-20 |
| Decision Date | 2009-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250365135992 | K090445 | 000 |
| 04250365135169 | K090445 | 000 |