The following data is part of a premarket notification filed by Robert Bosch Corp. with the FDA for Hearing Aid Analysis System.
| Device ID | K853271 |
| 510k Number | K853271 |
| Device Name: | HEARING AID ANALYSIS SYSTEM |
| Classification | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| 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 | ETW |
| CFR Regulation Number | 874.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-05 |
| Decision Date | 1986-01-16 |