SOMNOLYZER 24X7
Ventilatory Effort Recorder
THE SIESTA GROUP NORTH AMERICA
The following data is part of a premarket notification filed by The Siesta Group North America with the FDA for Somnolyzer 24x7.
Pre-market Notification Details
| Device ID | K083620 |
| 510k Number | K083620 |
| Device Name: | SOMNOLYZER 24X7 |
| Classification | Ventilatory Effort Recorder |
| Applicant | THE SIESTA GROUP NORTH AMERICA 990 WASHINGTON STREET SUITE 204 Dedham, MA 02026 |
| Contact | Zvi Ladin |
| Correspondent | Zvi Ladin THE SIESTA GROUP NORTH AMERICA 990 WASHINGTON STREET SUITE 204 Dedham, MA 02026 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-08 |
| Decision Date | 2009-03-06 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959006164 | K083620 | 000 |
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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