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510(k) K222902

Electrocardiograph: SE-1200 Pro and SE-1201 Pro by Edan Instruments, Inc. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2023
Date Received
September 23, 2022
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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