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 Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K161431
Device Name SimplECG
Applicant
Nanowear, Inc.
53 Boerum Place, Suite 3f
Brooklyn,  NY  11201
Applicant Contact Venkatesh Varadan
Correspondent
Graematter, Inc.
1324 Clarkson Clayton Center
St Louis,  MO  63011
Correspondent Contact Melissa Walker
Regulation Number870.2920
Classification Product Code
DXH  
Date Received05/24/2016
Decision Date 11/30/2016
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
-
-