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510(k) K945130

BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER by Braemar Corp. — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1995
Date Received
October 19, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Magnetic Tape, Medical
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Braemar Corp.

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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)
  • 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)

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