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510(k) K120865

RSCRIBE ELECTROCARDIOGRAPH by Mortara Instrument, Inc. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2012
Date Received
March 22, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type

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  • K141811 — MORTARA MONITORING WAVEFORM VIEWER (November 19, 2014)

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