The following data is part of a premarket notification filed by Myo-tronics, Inc. with the FDA for Esg-1 Electrosonogram (esg-1).
| Device ID | K970116 |
| 510k Number | K970116 |
| Device Name: | ESG-1 ELECTROSONOGRAM (ESG-1) |
| Classification | Device, Dental Sonography, For Monitoring Jaw Sounds |
| Applicant | MYO-TRONICS, INC. 15425 - 33RD AVENUE SOUTH Tukwila, WA 98188 |
| Contact | Fray Adib |
| Correspondent | Fray Adib MYO-TRONICS, INC. 15425 - 33RD AVENUE SOUTH Tukwila, WA 98188 |
| Product Code | NFQ |
| CFR Regulation Number | 872.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-13 |
| Decision Date | 1997-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D79209830 | K970116 | 000 |