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 monitor, physiological, patient (without arrhythmia detection or alarms)
510(k) Number K043368
Device Name VITELCARE TURTLE, MODEL 400
Applicant
VISUAL TELECOMMUNICATIONS NETWORK, INC.
8201 GREENSBORO DR., STE. 600
MCLEAN,  VA  22102
Applicant Contact ALLEN IZADPANAH
Correspondent
VISUAL TELECOMMUNICATIONS NETWORK, INC.
8201 GREENSBORO DR., STE. 600
MCLEAN,  VA  22102
Correspondent Contact ALLEN IZADPANAH
Regulation Number870.2300
Classification Product Code
MWI  
Date Received12/08/2004
Decision Date 02/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-