The following data is part of a premarket notification filed by Monitor Instruments, Inc. with the FDA for The Monitor Model Mi-1.2.3 Tone Count Screen Audio.
| Device ID | K922383 |
| 510k Number | K922383 |
| Device Name: | THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO |
| Classification | Audiometer |
| Applicant | MONITOR INSTRUMENTS, INC. 437 DIMMOCKS MILL RD. Hillsborough, NC 27278 |
| Contact | Mack J Preslar |
| Correspondent | Mack J Preslar MONITOR INSTRUMENTS, INC. 437 DIMMOCKS MILL RD. Hillsborough, NC 27278 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-20 |
| Decision Date | 1993-01-15 |