• 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 K183425
Device Name CARDIOVIT AT-102 G2
Applicant
Schiller AG
Altgasse 68
baar zug,  CH 6341
Applicant Contact sabina standiford
Correspondent
Arazy Group Consultants Inc.
68 Southwood Terrace
southbury,  CT  06488
Correspondent Contact ray kelly
Regulation Number870.2340
Classification Product Code
DPS  
Date Received12/11/2018
Decision Date 03/02/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-