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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
  1.  K182456  Study Watch
  2.  K192415  Study Watch with Irregular Pulse Monitor
VITASYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 4 4
2017 4 4
2020 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Incorrect Interpretation of Signal 1 1
Patient-Device Incompatibility 1 1
Calibration Problem 1 1
Communication or Transmission Problem 1 1
Device Operates Differently Than Expected 1 1
EKG/ECG Monitor 1 1
Electrode 1 1
Display or Visual Feedback Problem 1 1
False Reading From Device Non-Compliance 1 1
Radio Signal Problem 1 1
Sensor 1 1
Vibration 1 1
Failure to Fire 1 1
Incorrect Device Or Component Shipped 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Itching Sensation 2 2
Myocardial Infarction 2 2
Anxiety 2 2
Burn, Thermal 1 1
No Information 1 1
Cardiac Arrest 1 1
Chest Pain 1 1
Hypoxia 1 1
Nausea 1 1
Pain 1 1
Weakness 1 1
Burning Sensation 1 1
Tingling 1 1
Erythema 1 1
Hypersensitivity/Allergic reaction 1 1
Muscle Spasm(s) 1 1
Skin Irritation 1 1
No Consequences Or Impact To Patient 1 1
Neck Pain 1 1
Palpitations 1 1
Sleep Dysfunction 1 1
No Known Impact Or Consequence To Patient 1 1

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