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 Device, Biofeedback
510(k) Number K983550
Device Name XYZ SYSTEM
Applicant
Bio-Monitoring International Corp.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact ANAND AKERKAR
Correspondent
Bio-Monitoring International Corp.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact ANAND AKERKAR
Regulation Number882.5050
Classification Product Code
HCC  
Date Received10/09/1998
Decision Date 01/07/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-