Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name calibrator, hearing aid / earphone and analysis systems
510(k) Number K853271
Device Name HEARING AID ANALYSIS SYSTEM
Applicant
ROBERT BOSCH CORP.
FLOWER FIELD BLDG. #17
MILL POND ROAD
ST. JAMES,  NY  11780
Applicant Contact CHERYL M LEISTER
Correspondent
ROBERT BOSCH CORP.
FLOWER FIELD BLDG. #17
MILL POND ROAD
ST. JAMES,  NY  11780
Correspondent Contact CHERYL M LEISTER
Regulation Number874.3310
Classification Product Code
ETW  
Date Received08/05/1985
Decision Date 01/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-