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510(k) K991441

CADENCE DOPPLER ULTRASOUND SYSTEM by Medasonics, Inc. — Product Code KNG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1999
Date Received
April 26, 1999
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 Medasonics, Inc.

  • K962796 — NEUROGUARD TRANSCRANIAL DOPPLER ULTRASOUND SYSTEM (January 21, 1997)
  • K961116 — FIRST BEAT/CARDIO BEAT/CALC (August 8, 1996)
  • K914862 — CEREBROVASCULAR DIAGNOSTIC SYSTEM; CDS (December 3, 1992)
  • K911453 — OBTRASOUND STETHOSCOPE FETAL CALC (June 20, 1991)
  • K882018 — MEDACORD PVL, PERSONAL VASCULAR LABORATORY (September 21, 1988)
  • K872292 — TRANSPECT TRANSCRANIAL DOPPLER (August 14, 1987)
  • K854734 — MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE (February 10, 1986)
  • K833588 — VASCULAR LABORATORY TREADMILL VT1 (November 14, 1983)
  • K837481 — BF24 DOPPLER MODEL P872 AND P874 (June 24, 1983)
  • K831393 — VASCULAB BLOOD PRESSURE CUFF (June 16, 1983)

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  • K232893 — Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fet (June 14, 2024)
  • 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)