• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • 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 show TPLC since Back to Search Results
Device transmitters and receivers, electrocardiograph, telephone
Regulation Description Telephone electrocardiograph transmitter and receiver.
Product CodeDXH
Regulation Number 870.2920
Device Class 2


Premarket Reviews
ManufacturerDecision
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 4
CARDIOCOMM SOLUTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
MEGA ELECTRONICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
VERILY LIFE SCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 2
VITASYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to Fire 1
Total Device Problems 1

Recalls
Manufacturer Recall Class Date Posted
1 Alivecor SFO III Feb-18-2015
2 Spacelabs Healthcare Inc II Oct-30-2015

-
-