• 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 K941848
Device Name INTERACOUSTICS. HEARING AID ANALYZER
Applicant
PRECISION ACOUSTICS IND., INC.
501 FIFTH AVE.
NEW YORK,  NY  10017
Applicant Contact MICHAEL DAVIS
Correspondent
PRECISION ACOUSTICS IND., INC.
501 FIFTH AVE.
NEW YORK,  NY  10017
Correspondent Contact MICHAEL DAVIS
Regulation Number874.3310
Classification Product Code
ETW  
Date Received04/14/1994
Decision Date 05/23/1994
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
-
-