OB1 Obstetrical Doppler
FDA 510(k) K033156 · D. E. Hokanson, Inc.
510(k) numberK033156
Submission
- Device name
- OB1 Obstetrical Doppler
- Applicant
- D. E. Hokanson, Inc.
Bellevue, WA, US - Received
- September 30, 2003
- Decision date
- December 9, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNG – Monitor, Ultrasonic, Fetal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2660
- Specialty
- Obstetrics/Gynecology
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| K242846 | Doppler FHR Detector (BF-500D+, BF-560)KNG · Traditional | Shenzhen Bestman Instrument Co., Ltd. | 06/26/2025SE |
| K233823 | Ultrasonic Fetal DopplerKNG · Traditional | Shenzhen Jamr Technology Co., Ltd. | 06/28/2024SE |
| K232893 | Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal…KNG · Traditional | Contec Medical Systems Co.,Ltd | 06/14/2024SE |
| K220245 | Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)KNG · Traditional | Contec Medical Systems Co.,Ltd | 09/28/2022SE |
| K211940 | Fetal DopplerKNG · Traditional | Shenzhen Taikang Medical Equipment Co., Ltd. | 01/07/2022SE |
| K212084 | Fetal DopplerKNG · Traditional | Shenzhen Mericonn Technology Co., Ltd. | 11/03/2021SE |
| K191110 | HeraBEAT USKNG · Traditional | Heramed, Ltd. | 11/14/2019SE |
| K182526 | Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B…KNG · Traditional | Vcomin Technology Limited | 05/29/2019SE |
| K182710 | Fetal Doppler, Model FD88KNG · Traditional | Shenzzhen Luckcome Technology Inc., Ltd. | 03/01/2019SE |
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| K982707 | EC6 PlethysmographJOM · Special | 08/26/1998SE |
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| K970570 | NIVP3 (Windows Version of NivpDQK · Traditional | 10/03/1997SE |
| K932852 | Non Invasive Vascular ProgramJOB · Traditional | 02/04/1994SE |
| K932812 | Ec 5R PlethysmographJEH · Traditional | 01/13/1994SE |
| K932851 | Disposable Penile Blood Pressure CuffsDXQ · Traditional | 11/15/1993SE |
| K905367 | E-20 Rapid Cuff InflatorDXN · Traditional | 03/06/1991SE |
| K901592 | Model MD-5 DopplerDXK · Traditional | 10/22/1990SE |
Questions and answers
When was OB1 Obstetrical Doppler cleared by the FDA?
OB1 Obstetrical Doppler (K033156) received a 510(k) decision of Substantially Equivalent on December 9, 2003, 70 days after the submission was received.
What is the product code of K033156?
The FDA product code is KNG – Monitor, Ultrasonic, Fetal, a Class II (moderate risk) device regulated under 21 CFR 884.2660.