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 Flowmeter, Blood, Cardiovascular
510(k) Number K062977
Device Name CRITIVIEW, MODEL CRV3
Applicant
Critisense , Ltd.
3460 Pt.e Creek Ct. #102
Bonita Springs,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
Critisense , Ltd.
3460 Pt.e Creek Ct. #102
Bonita Springs,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number870.2100
Classification Product Code
DPW  
Subsequent Product Codes
EZL   KHO  
Date Received09/29/2006
Decision Date 02/28/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-