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510(k) K112573

EZSLEEP SLEEP QUALITY RECORDER by Platinum Team Co., Ltd. — Product Code MWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2012
Date Received
September 6, 2011
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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