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510(k) K951449

MODEL KM-25 by Koven Technology, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1996
Date Received
March 29, 1995
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

Other clearances by Koven Technology, Inc.

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  • K080178 — VALVULOTOME BY KOVEN (July 28, 2008)
  • K050601 — SMARTDOP 45 VASCULAR DOPPLER (April 15, 2005)
  • K031931 — ECHO SOUNDER EX-101EX 8 MHZ (February 13, 2004)
  • K031504 — ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX (July 18, 2003)
  • K023143 — ECHO SOUNDER, ES-102EX (December 19, 2002)
  • K010452 — BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T (February 12, 2002)

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