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 System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K933100
Device Name ARC-600
Applicant
B C Medical , Ltd.
3755 Richelieu
St-Hubert, Qc Canada
J3y 7p9,  CA
Applicant Contact YVAN GIARD
Correspondent
B C Medical , Ltd.
3755 Richelieu
St-Hubert, Qc Canada
J3y 7p9,  CA
Correspondent Contact YVAN GIARD
Regulation Number892.1650
Classification Product Code
JAA  
Date Received06/24/1993
Decision Date 11/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-