The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Model 8233 Hearing Instrument.
| Device ID | K943854 |
| 510k Number | K943854 |
| Device Name: | 3M MODEL 8233 HEARING INSTRUMENT |
| Classification | Hearing Aid, Air Conduction |
| Applicant | 3M COMPANY 3M CENTER, BLDG. 260-6A-19 St. Paul, MN 55144 -1000 |
| Contact | Joyce Eyerly |
| Correspondent | Joyce Eyerly 3M COMPANY 3M CENTER, BLDG. 260-6A-19 St. Paul, MN 55144 -1000 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-08 |
| Decision Date | 1995-01-24 |