• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name confocal optical imaging
510(k) Number K122042
Models ALVEOFLEX, ALVEOFLEX M, F-400,F-400 V2, GASTROFLEX, GASTROFLEX UHD, GASTROFLEX M, COLOFLEX, COLOFLEX UHD
Device Name CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES
Original Applicant
MAUNA KEA TECHNOLOGIES
8 snowberry court
orinda,  CA  94563
Original Contact michael daniel
Regulation Number876.1500
Classification Product Code
OWN  
Date Received07/12/2012
Decision Date 09/04/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-