Obstetrical Doppler

FDA 510(k) K841805 · Epcom Medical Systems, Inc.

Substantially Equivalent

510(k) numberK841805

Submission

Device name
Obstetrical Doppler
Applicant
Epcom Medical Systems, Inc.
Mchenry, IL, US
Received
May 1, 1984
Decision date
June 19, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KNG – Monitor, Ultrasonic, Fetal
Device class
Class II (moderate risk)
Regulation
21 CFR 884.2660
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code KNG

510(k)DeviceApplicantDecision
K252669Fetal Doppler U8-25, U9-25KNG · Traditional Zhongshan Xiaolan Town Senlan Electronic Factory01/08/2026SE
K242846Doppler FHR Detector (BF-500D+, BF-560)KNG · Traditional Shenzhen Bestman Instrument Co., Ltd.06/26/2025SE
K233823Ultrasonic Fetal DopplerKNG · Traditional Shenzhen Jamr Technology Co., Ltd.06/28/2024SE
K232893Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal…KNG · Traditional Contec Medical Systems Co.,Ltd06/14/2024SE
K220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)KNG · Traditional Contec Medical Systems Co.,Ltd09/28/2022SE
K211940Fetal DopplerKNG · Traditional Shenzhen Taikang Medical Equipment Co., Ltd.01/07/2022SE
K212084Fetal DopplerKNG · Traditional Shenzhen Mericonn Technology Co., Ltd.11/03/2021SE
K191110HeraBEAT™ USKNG · Traditional Heramed, Ltd.11/14/2019SE
K182526Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B…KNG · Traditional Vcomin Technology Limited05/29/2019SE
K182710Fetal Doppler, Model FD88KNG · Traditional Shenzzhen Luckcome Technology Inc., Ltd.03/01/2019SE

More from Shenzzhen Luckcome Technology Inc., Ltd.

510(k)DeviceDecision
K910518Glove-N-Gel Amniotomy KitHGE · Traditional 05/09/1991SESK
K905812Intrauterine Catheter SetHGS · Traditional 01/31/1991SE
K881414CervicathHDR · Traditional 06/14/1988SE
K871079Fetalflex Fetal ElectrodeHGP · Traditional 07/13/1987SE
K8443381URO-LOG Home Diagnostic PackFFG · Traditional 02/25/1985SE
K844503Urostresstik Diagnostic Cystometry PackFAP · Traditional 01/02/1985SE
K831115Epcom EMS-320 Remote MonitorscopeHGM · Traditional 08/12/1983SE
K831114Epcom EMS-330 Freedom I Teledop ObstetHGM · Traditional 08/12/1983SE
K831113Epcom EMS-310 Intrapartum MonitorHGM · Traditional 08/12/1983SE
K831112Epcom VCU-1 Vacuum System & CuretteHHI · Traditional 06/30/1983SE

Questions and answers

When was Obstetrical Doppler cleared by the FDA?

Obstetrical Doppler (K841805) received a 510(k) decision of Substantially Equivalent on June 19, 1984, 49 days after the submission was received.

What is the product code of K841805?

The FDA product code is KNG – Monitor, Ultrasonic, Fetal, a Class II (moderate risk) device regulated under 21 CFR 884.2660.