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510(k) K072008

BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER by Braemar, Inc. — Product Code DRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2007
Date Received
July 23, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class
Class II
Regulation Number
870.2910
Review Panel
CV
Submission Type

Other clearances by Braemar, Inc.

  • K081444 — BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM (July 31, 2008)
  • 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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