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 Tester, Auditory Impedance
510(k) Number K863353
Device Name MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER)
Applicant
Grason-Stadler, Inc.
537 Great Rd., P.O. Box 1400
Littleton,  MA  01460
Applicant Contact JANICE E PAINTER
Correspondent
Grason-Stadler, Inc.
537 Great Rd., P.O. Box 1400
Littleton,  MA  01460
Correspondent Contact JANICE E PAINTER
Regulation Number874.1090
Classification Product Code
ETY  
Date Received08/29/1986
Decision Date 11/03/1986
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
Predetermined Change
Control Plan Authorized		 No
-
-