The following data is part of a premarket notification filed by Tomed Dr. Toussaint Gmbh with the FDA for Anti-snoring / Sleep Apnea Device.
| Device ID | K061688 |
| 510k Number | K061688 |
| Device Name: | ANTI-SNORING / SLEEP APNEA DEVICE |
| Classification | Device, Anti-snoring |
| Applicant | TOMED DR. TOUSSAINT GMBH LINDBERGHSTR. 3A Bensheim, DE D-64625 |
| Contact | Winfried Toussaint |
| Correspondent | Winfried Toussaint TOMED DR. TOUSSAINT GMBH LINDBERGHSTR. 3A Bensheim, DE D-64625 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-15 |
| Decision Date | 2006-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260383460341 | K061688 | 000 |
| 04260383460297 | K061688 | 000 |