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 K890124
Device Name ILO88 OTODYNAMIC ANALYZER SCREENING 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 Number874.1050
Classification Product Code
EWO  
Date Received01/11/1989
Decision Date 07/14/1989
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
-
-