The following data is part of a premarket notification filed by Thorasys Thoracic Medical Systems, Inc. with the FDA for Tremoflo C-100 Airwave Oscillometry System.
| Device ID | K170185 |
| 510k Number | K170185 |
| Device Name: | TremoFlo C-100 Airwave Oscillometry System |
| Classification | Impedance Measuring Device Utilizing Oscillation Techniques |
| Applicant | THORASYS Thoracic Medical Systems, Inc. 6560 Avenue De L'Esplanade Suite #103 Montreal, CA H2v 4l5 |
| Contact | Sebastien Jutras |
| Correspondent | E.j. Smith Smith Assoicates 1468 Harwell Avenue Crofton, MD 21114 |
| Product Code | PNV |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-23 |
| Decision Date | 2017-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540261025853 | K170185 | 000 |
| 07540261016400 | K170185 | 000 |
| 07540261015243 | K170185 | 000 |
| 07540261014215 | K170185 | 000 |
| 07540261013454 | K170185 | 000 |
| 07540261013362 | K170185 | 000 |
| 07540261009860 | K170185 | 000 |
| 07540261019234 | K170185 | 000 |
| 07540261010590 | K170185 | 000 |