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510(k) K982986

TUBING BLOOD FLOW METER MODEL NUMBER HD-800 by Koven Technology, Inc. — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1998
Date Received
August 26, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Blood, Cardiovascular
Device Class
Class II
Regulation Number
870.2100
Review Panel
CV
Submission Type

Other clearances by Koven Technology, Inc.

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  • K131623 — SMARTDOP XT (January 17, 2014)
  • 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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