The following data is part of a premarket notification filed by Atmos Inc. with the FDA for Atmos E 201 Thorax And Atmos S 201 Thorax.
| Device ID | K103042 |
| 510k Number | K103042 |
| Device Name: | ATMOS E 201 THORAX AND ATMOS S 201 THORAX |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | ATMOS INC. 3717 HUCKLEBERRY ROAD Allentown, PA 18104 |
| Contact | Marco Schlegel |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-10-14 |
| Decision Date | 2011-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250365132304 | K103042 | 000 |