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510(k) K081444

BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM by Braemar, Inc. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2008
Date Received
May 22, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Braemar, Inc.

  • K072008 — BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER (October 3, 2007)
  • K071733 — DL900 SERIES HOLTER RECORDER (July 24, 2007)
  • K071011 — MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER (April 27, 2007)
  • K042469 — BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER (October 6, 2004)
  • K030856 — ER800 SERIES ECG EVENT RECORDER (March 28, 2003)
  • K993618 — DXP1000 HOLTER RECORDER (November 24, 1999)
  • K993617 — DIGITRAKPLUS HOLTER RECORDER (November 24, 1999)
  • K981394 — BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720 (September 28, 1998)
  • K945130 — BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER (April 12, 1995)

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