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 Stimulator, Auditory, Evoked Response
510(k) Number K810473
Device Name MK6 ERA SYSTEM
Applicant
Amplaid USA, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Amplaid USA, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received02/23/1981
Decision Date 04/29/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-