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510(k) K030856

ER800 SERIES ECG EVENT RECORDER by Braemar Corp. — Product Code MWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2003
Date Received
March 18, 2003
Clearance Type
Special
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

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  • 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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