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510(k) K780043

ESIS MODULE by Datascope Corp. — Product Code DRR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1978
Date Received
January 9, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier And Signal Conditioner, Biopotential
Device Class
Class II
Regulation Number
870.2050
Review Panel
CV
Submission Type

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