PD-100 Series Ultrasonic Pocket Doppler
FDA 510(k) K111934 · Advanced Instrumentations, Inc.
510(k) numberK111934
Submission
- Device name
- PD-100 Series Ultrasonic Pocket Doppler
- Applicant
- Advanced Instrumentations, Inc.
Hialeah, FL, US - Received
- July 8, 2011
- Decision date
- September 22, 2011
- 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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| K252669 | Fetal Doppler U8-25, U9-25KNG · Traditional | Zhongshan Xiaolan Town Senlan Electronic Factory | 01/08/2026SE |
| 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 |
More from Shenzzhen Luckcome Technology Inc., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K172931 | DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemIYO · Abbreviated | 12/01/2017SE |
| K172055 | DUS-7000 Digital Color Doppler Ultrasound SystemIYN · Abbreviated | 08/31/2017SE |
| K141194 | FM-3000 Fetal MonitorHGM · Traditional | 11/19/2014SE |
| K132077 | Patient MonitorMHX · Traditional | 04/23/2014SE |
| K132059 | Diagnostic Ultrasound SystemIYN · Traditional | 10/25/2013SE |
| K123048 | Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProMHX · Traditional | 01/11/2013SE |
| K120075 | AM-6000 Anesthesia MachineBSZ · Traditional | 01/26/2012SE |
| K112317 | FM-9000 Plus Fetal and Maternal MonitorHGM · Traditional | 12/21/2011SE |
| K112529 | TD-5000 & TD-6000 Ultrasonic Tabletop DopplerKNG · Traditional | 10/27/2011SE |
| K112022 | DUS-3000/DUS-3000PLUS Digital Ultrasonic Diagnostic Imaging SystemIYO · Traditional | 09/22/2011SE |
Questions and answers
When was PD-100 Series Ultrasonic Pocket Doppler cleared by the FDA?
PD-100 Series Ultrasonic Pocket Doppler (K111934) received a 510(k) decision of Substantially Equivalent on September 22, 2011, 76 days after the submission was received.
What is the product code of K111934?
The FDA product code is KNG – Monitor, Ultrasonic, Fetal, a Class II (moderate risk) device regulated under 21 CFR 884.2660.