The following data is part of a premarket notification filed by Robert Bosch Corp. with the FDA for Body Hearing Aids Mt 80 Sp.
| Device ID | K850185 |
| 510k Number | K850185 |
| Device Name: | BODY HEARING AIDS MT 80 SP |
| Classification | Hearing Aid, Air Conduction |
| Applicant | ROBERT BOSCH CORP. FLOWER FIELD BLDG. #17 MILL POND ROAD St. James, NY 11780 |
| Contact | Cheryl M Leister |
| Correspondent | Cheryl M Leister ROBERT BOSCH CORP. FLOWER FIELD BLDG. #17 MILL POND ROAD St. James, NY 11780 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-18 |
| Decision Date | 1985-03-25 |