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510(k) K800768

VASCULAB BI-DIRECTIONAL DOPPLER, #D10 by Medasonics, Inc. — Product Code JAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1980
Date Received
April 7, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Ultrasonic, Nonfetal
Device Class
Class II
Regulation Number
892.1540
Review Panel
RA
Submission Type

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  • K833588 — VASCULAR LABORATORY TREADMILL VT1 (November 14, 1983)
  • K837481 — BF24 DOPPLER MODEL P872 AND P874 (June 24, 1983)

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