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 K904270
Device Name BIOLINK AUDIOMETER SOFTWARE ACCESSORY
Applicant
MICRO AUDIOMETRICS CORP.
2200 SO. RIDGEWOOD AVENUE,
US#1
SOUTH DAYTONA,  FL  32119
Applicant Contact AARON MARGOSIS
Correspondent
MICRO AUDIOMETRICS CORP.
2200 SO. RIDGEWOOD AVENUE,
US#1
SOUTH DAYTONA,  FL  32119
Correspondent Contact AARON MARGOSIS
Regulation Number874.1050
Classification Product Code
EWO  
Date Received09/18/1990
Decision Date 10/09/1990
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
-
-