Home / 510(k) Clearances / K033156

510(k) K033156

OB1 OBSTETRICAL DOPPLER by D. E. Hokanson, Inc. — Product Code KNG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2003
Date Received
September 30, 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 D. E. Hokanson, Inc.

  • K041689 — POLYURETHANE BLOOD PRESSURE CUFFS (August 6, 2004)
  • K023707 — A16 BLOOD FLOW MEASUREMENT SYSTEM (February 12, 2003)
  • K982707 — EC6 PLETHYSMOGRAPH (August 26, 1998)
  • K973426 — ANS 2000 ECG MONITOR AND RESPIRATION PACER (August 12, 1998)
  • K970570 — NIVP3 (WINDOWS VERSION OF NIVP (October 3, 1997)
  • K932852 — NON INVASIVE VASCULAR PROGRAM (February 4, 1994)
  • K932812 — EC 5R PLETHYSMOGRAPH (January 13, 1994)
  • K932851 — DISPOSABLE PENILE BLOOD PRESSURE CUFFS (November 15, 1993)
  • K905367 — E-20 RAPID CUFF INFLATOR (March 6, 1991)
  • K901592 — MODEL MD-5 DOPPLER (October 22, 1990)

Other clearances for product code KNG

  • K252669 — Fetal Doppler U8-25, U9-25 (January 8, 2026)
  • K242846 — Doppler FHR Detector (BF-500D+, BF-560) (June 26, 2025)
  • K233823 — Ultrasonic Fetal Doppler (June 28, 2024)
  • 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)