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510(k) K111805

ECG SERIES ELECTROCARDIOGRAPH by Advanced Instrumentations, Inc. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2011
Date Received
June 27, 2011
Clearance Type
Traditional
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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  • K111934 — PD-100 SERIES ULTRASONIC POCKET DOPPLER (September 22, 2011)

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