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510(k) K961116

FIRST BEAT/CARDIO BEAT/CALC by Medasonics, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1996
Date Received
March 20, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

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  • K837481 — BF24 DOPPLER MODEL P872 AND P874 (June 24, 1983)
  • K831393 — VASCULAB BLOOD PRESSURE CUFF (June 16, 1983)

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