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 K903066
Device Name AMPLAID 770 ADMITTANCE METER
Applicant
Amplus Corp.
65 Bristlecone Way
Boulder,  CO  80304
Applicant Contact GIAN MAZZONI
Correspondent
Amplus Corp.
65 Bristlecone Way
Boulder,  CO  80304
Correspondent Contact GIAN MAZZONI
Regulation Number874.1090
Classification Product Code
ETY  
Date Received07/12/1990
Decision Date 10/24/1990
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
-
-