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 K953684
Device Name GSI 61 CLINICAL AUDIOMETER
Applicant
GRASON-STADLER, INC.
1 WESTCHESTER DR.
MILFORD,  NH  03055 -3056
Applicant Contact JANICE E PAINTER
Correspondent
GRASON-STADLER, INC.
1 WESTCHESTER DR.
MILFORD,  NH  03055 -3056
Correspondent Contact JANICE E PAINTER
Regulation Number874.1050
Classification Product Code
EWO  
Date Received08/03/1995
Decision Date 10/27/1995
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
-
-