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510(k) K210140

electrocardiograph: SE-1202 by Edan Instruments, Inc. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2021
Date Received
January 19, 2021
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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Other clearances for product code DPS

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  • K241217 — CloudHRV™ System (100-01-001) (January 16, 2025)
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