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 electrocardiograph
510(k) Number K170182
Device Name CARDIOVIT FT-1
Applicant
SCHILLER AG
ALTGASSE 68
baar,  CH ch-6371
Applicant Contact zhenrong yu
Correspondent
ZOE MEDICAL, INC
460 BOSTON STREET
topsfield,  MA  01983
Correspondent Contact jim chickering
Regulation Number870.2340
Classification Product Code
DPS  
Date Received01/23/2017
Decision Date 07/19/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-