The following data is part of a premarket notification filed by Trudell Medical International with the FDA for Versapap Positive Airway Pressure (pap) Device.
| Device ID | K173918 |
| 510k Number | K173918 |
| Device Name: | VersaPAP Positive Airway Pressure (PAP) Device |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | Trudell Medical International 725 Third Street London, CA N5v 5g4 |
| Contact | Marianne Tanton |
| Correspondent | Marianne Tanton Trudell Medical International 725 Third Street London, CA N5v 5g4 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-22 |
| Decision Date | 2018-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 62860121501028 | K173918 | 000 |
| 62860121501035 | K173918 | 000 |
| 00762860215054 | K173918 | 000 |
| 00762860215016 | K173918 | 000 |