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 |