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, angiographic
510(k) Number K062360
Device Name BRANSIST SAFIRE
Applicant
SHIMADZU CORP.
20101 SOUTH VERMONT AVE.
TORRANCE,  CA  90502 -1328
Applicant Contact RANDAL WALKER
Correspondent
SHIMADZU CORP.
20101 SOUTH VERMONT AVE.
TORRANCE,  CA  90502 -1328
Correspondent Contact RANDAL WALKER
Regulation Number892.1600
Classification Product Code
IZI  
Date Received08/14/2006
Decision Date 10/05/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-