The following data is part of a premarket notification filed by Somnomed Inc. with the FDA for Somnodent Classic With Dentitrac Micro-recorder, Somnodent Flex With Dentitrac Micro-recorder, Somnodent Herbst Advance (classic Or Flex Retention) With Dentitrac Micro-recorder, Somnodent G2 (classic Or Flex Retention) With Dentitrac Micro-recorder,.
| Device ID | K150369 |
| 510k Number | K150369 |
| Device Name: | SomnoDent Classic With DentiTrac Micro-recorder, SomnoDent Flex With DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic Or Flex Retention) With DentiTrac Micro-recorder, SomnoDent G2 (Classic Or Flex Retention) With DentiTrac Micro-recorder, |
| Classification | Sleep Appliances With Patient Monitoring |
| Applicant | SOMNOMED INC. 7460 Warren Pkwy Ste 190 Frisco, TX 75034 |
| Contact | Kien T. Nguyen |
| Correspondent | Kien T. Nguyen SOMNOMED, INC. 7460 WARREN PARKWAY, SUITE 190 Frisco, TX 75035 |
| Product Code | PLC |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-13 |
| Decision Date | 2015-06-18 |
| Summary: | summary |