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510(k) K102723

MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS by Memtec Corp. — Product Code MWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2010
Date Received
September 21, 2010
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

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