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510(k) K875334

KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM by Kontron Instruments, Inc. — Product Code HGL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1988
Date Received
December 30, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Obstetric
Device Class
Class II
Regulation Number
884.2960
Review Panel
OB
Submission Type

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