The following data is part of a premarket notification filed by Microbio-medics, Inc. with the FDA for 321q Minimum Energy Tinnitus Suppressor.
| Device ID | K922572 |
| 510k Number | K922572 |
| Device Name: | 321Q MINIMUM ENERGY TINNITUS SUPPRESSOR |
| Classification | Masker, Tinnitus |
| Applicant | MICROBIO-MEDICS, INC. 1710 SHELBY OAKS DR. SUITE #21 Memphis, TN 38134 |
| Contact | Timothy D Gooeh |
| Correspondent | Timothy D Gooeh MICROBIO-MEDICS, INC. 1710 SHELBY OAKS DR. SUITE #21 Memphis, TN 38134 |
| Product Code | KLW |
| CFR Regulation Number | 874.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-01 |
| Decision Date | 1992-11-02 |