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510(k) K031504

ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX by Koven Technology, Inc. — Product Code KNG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2003
Date Received
May 14, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Ultrasonic, Fetal
Device Class
Class II
Regulation Number
884.2660
Review Panel
OB
Submission Type

Other clearances by Koven Technology, Inc.

  • K201114 — Bidop 7 (January 5, 2021)
  • K153762 — Smartdop XT6 (May 25, 2016)
  • K143332 — Fast Sphyg by Koven (April 14, 2015)
  • 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)
  • K023143 — ECHO SOUNDER, ES-102EX (December 19, 2002)
  • K010452 — BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T (February 12, 2002)
  • K982986 — TUBING BLOOD FLOW METER MODEL NUMBER HD-800 (November 24, 1998)

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  • K220245 — Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) (September 28, 2022)
  • K211940 — Fetal Doppler (January 7, 2022)
  • K212084 — Fetal Doppler (November 3, 2021)
  • K191110 — HeraBEAT™ US (November 14, 2019)
  • K182526 — Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD- (May 29, 2019)
  • K182710 — Fetal Doppler, Model FD88 (March 1, 2019)