SOMNOLYZER 24X7
Ventilatory Effort Recorder
RESPIRONICS, INC.
The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Somnolyzer 24x7.
Pre-market Notification Details
| Device ID | K131994 |
| 510k Number | K131994 |
| Device Name: | SOMNOLYZER 24X7 |
| Classification | Ventilatory Effort Recorder |
| Applicant | RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Contact | Daniela Aizpitarte |
| Correspondent | Daniela Aizpitarte 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 | 2013-06-28 |
| Decision Date | 2013-10-17 |
| Summary: | summary |
Trademark Results [SOMNOLYZER 24X7]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOMNOLYZER 24X7 79016696 3211566 Dead/Cancelled |
THE SIESTA GROUP SCHLAFANALYSE GMBH 2005-10-05 |
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