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 Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K880036
Device Name BIOMA 5000
Applicant
E.B.S., Inc.
660 Rochon
St-Laurent (Quebec)
Canada,  CA H4L 1T4
Applicant Contact SYLVAIN BOUCHER
Correspondent
E.B.S., Inc.
660 Rochon
St-Laurent (Quebec)
Canada,  CA H4L 1T4
Correspondent Contact SYLVAIN BOUCHER
Regulation Number870.2910
Classification Product Code
DRG  
Date Received01/05/1988
Decision Date 03/07/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-