SomnaPatch
Ventilatory Effort Recorder
Respironics, Inc.
The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Somnapatch.
Pre-market Notification Details
| Device ID | K183625 |
| 510k Number | K183625 |
| Device Name: | SomnaPatch |
| Classification | Ventilatory Effort Recorder |
| Applicant | Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 |
| Contact | Amy Panzik |
| Correspondent | Amy Panzik Respironics, Inc. 1740 Golden Mile Highway Monroeville, PA 15146 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-26 |
| Decision Date | 2019-10-18 |
Trademark Results [SomnaPatch]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOMNAPATCH 87544525 5548579 Live/Registered |
KONINKLIJKE PHILIPS N.V. 2017-07-26 |
 SOMNAPATCH 87339246 not registered Dead/Abandoned |
KONINKLIJKE PHILIPS N.V. 2017-02-16 |
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