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 Audiometer
510(k) Number K930260
Device Name ACOUSTIC ANALYZER AA30
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 Number874.1050
Classification Product Code
EWO  
Subsequent Product Code
KHL  
Date Received01/19/1993
Decision Date 07/13/1993
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
-
-