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 Confocal Optical Imaging
510(k) Number K111047
Device Name CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES
Applicant
MAUNA KEA TECHNOLOGIES INC.
660 NEWTOWN-YARDLEY RD.
SUITE 107
NEWTON,  PA  18940
Applicant Contact CHRIS TIHANSKY
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
NEWTON,  CT  06470
Correspondent Contact MICHAEL S OGUNLEYE
Regulation Number876.1500
Classification Product Code
OWN  
Date Received04/15/2011
Decision Date 08/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
-
-