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 Amplifier, Physiological Signal
510(k) Number K943673
Device Name MMC AMPLIFIER
Applicant
Melville Software , Ltd.
350 Sparks St.
Suite 1007
Ottawa, Ontario,  CA K1R 7S8
Applicant Contact Tom Anderson
Correspondent
Melville Software , Ltd.
350 Sparks St.
Suite 1007
Ottawa, Ontario,  CA K1R 7S8
Correspondent Contact Tom Anderson
Regulation Number882.1835
Classification Product Code
GWL  
Date Received07/26/1994
Decision Date 10/26/1994
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
-
-