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 K133703
Device Name PHYSIOGLOVE ET SYSTEM
Applicant
COMMWELL R&D LTD.
555 THIRTEENTH STREET NW
washington,  DC  20004
Applicant Contact jonathon kahan
Correspondent
COMMWELL R&D LTD.
555 THIRTEENTH STREET NW
washington,  DC  20004
Correspondent Contact jonathon kahan
Regulation Number870.2920
Classification Product Code
DXH  
Subsequent Product Code
DPS  
Date Received12/03/2013
Decision Date 08/18/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-