The following data is part of a premarket notification filed by Monitor Instruments, Inc. with the FDA for The Monitor/demlar Model Mi-5000 Audiometer.
| Device ID | K913356 |
| 510k Number | K913356 |
| Device Name: | THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER |
| Classification | Audiometer |
| Applicant | MONITOR INSTRUMENTS, INC. 605 EASTOWNE DR. Chapel Hill, NC 27514 |
| Contact | Mack J Preslar |
| Correspondent | Mack J Preslar MONITOR INSTRUMENTS, INC. 605 EASTOWNE DR. Chapel Hill, NC 27514 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-30 |
| Decision Date | 1991-12-05 |