FDA 510(k), K052767, AFIBALERT ATRIAL FIBRILLATION DETECTOR

FDA 510(k), K052767, AFIBALERT ATRIAL FIBRILLATION DETECTOR

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510(K) Number: K052767
Device Name: AFIBALERT ATRIAL FIBRILLATION DETECTOR
Manufacturer: LECHNOLOGIES RESEARCH INC.
Device Classification Name: Transmitters And Receivers, Electrocardiograph, Telephone
Regulation Number: 870.2920
Classification Product Code: DXH
Date Received: 09/30/2005
Decision Date: 06/23/2006
Regulation Medical Specialty: Cardiovascular
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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