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510(k) K981394

BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720 by Braemar Corp. — Product Code DXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1998
Date Received
April 17, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Device Class
Class II
Regulation Number
870.2920
Review Panel
CV
Submission Type

Other clearances by Braemar Corp.

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  • 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)
  • K993617 — DIGITRAKPLUS HOLTER RECORDER (November 24, 1999)
  • K993618 — DXP1000 HOLTER RECORDER (November 24, 1999)
  • K945130 — BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER (April 12, 1995)

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