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510(k) K173461

ECG recorder and Arrhythmia Detector by Smart Solutions Technologies SL — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2018
Date Received
November 7, 2017
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

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