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510(k) K042469

BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER by Braemar, Inc. — Product Code MWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2004
Date Received
September 13, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph, Ambulatory (Without Analysis)
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Braemar, Inc.

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  • K071733 — DL900 SERIES HOLTER RECORDER (July 24, 2007)
  • K071011 — MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER (April 27, 2007)
  • K030856 — ER800 SERIES ECG EVENT RECORDER (March 28, 2003)
  • K993617 — DIGITRAKPLUS HOLTER RECORDER (November 24, 1999)
  • K993618 — DXP1000 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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