The following data is part of a premarket notification filed by Myo-tronics, Inc. with the FDA for Electrosonogram Esg-1.
Device ID | K905449 |
510k Number | K905449 |
Device Name: | ELECTROSONOGRAM ESG-1 |
Classification | Device, Dental Sonography, For Monitoring Jaw Sounds |
Applicant | MYO-TRONICS, INC. 720 OLIVE WAY SUITE 800 Seattle, WA 98101 |
Contact | Fray Adib |
Correspondent | Fray Adib MYO-TRONICS, INC. 720 OLIVE WAY SUITE 800 Seattle, WA 98101 |
Product Code | NFQ |
CFR Regulation Number | 872.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-05 |
Decision Date | 1991-04-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ELECTROSONOGRAM ESG-1 73823704 1602087 Dead/Cancelled |
MYO-TRONICS, INC. 1989-09-01 |