510(k) K080087
- Device
- SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR
- Applicant
- EDAN INSTRUMENTS, INC.
- 510(k) number
- K080087
- Product code
- KNG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-03-11
- Date received
- 2008-01-11
- Regulation
- 884.2660
- Classification name
- Monitor, Ultrasonic, Fetal
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM STERN
- Address
- 1 Odell Plz. Yonkers NY US 10701 10701
FDA Registration Numbers#
- 3027344406
- 3012725363
- 3016587556
- 3043709870
- 1450908
- 3010395077
- 1000122786
- 3015007456
- 3017140411
- 1216677
- 3010611950
- 3032109
- 3003971136
- 3009499478
- 3004485927
- 3010852191
- 1066270
- 3010390468
- 1061927
- 3008457078
- 3008973759
- 3017207990
- 3008756262
- 3005569927
- 3030151584
- 1000589001
- 3017520431
- 3017195985
- 3016838609
- 3006979678
Source Documents#
Other 510(k) Records For Product Code KNG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252669 | Fetal Doppler U8-25, U9-25 | Zhongshan Xiaolan Town Senlan Electronic Factory | 2026-01-08 |
| K242846 | Doppler FHR Detector (BF-500D+, BF-560) | Shenzhen Bestman Instrument Co., Ltd. | 2025-06-26 |
| K233823 | Ultrasonic Fetal Doppler | Shenzhen Jamr Technology Co., Ltd. | 2024-06-28 |
| K232893 | Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) | Contec Medical Systems Co.,Ltd | 2024-06-14 |
| K220245 | Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) | Contec Medical Systems Co.,Ltd | 2022-09-28 |
| K211940 | Fetal Doppler | Shenzhen Taikang Medical Equipment Co., Ltd. | 2022-01-07 |
| K212084 | Fetal Doppler | Shenzhen Mericonn Technology Co., Ltd. | 2021-11-03 |
| K191110 | HeraBEAT™ US | Heramed, Ltd. | 2019-11-14 |
| K182526 | Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) | Vcomin Technology Limited | 2019-05-29 |
| K182710 | Fetal Doppler, Model FD88 | Shenzzhen Luckcome Technology Inc., Ltd. | 2019-03-01 |
| K182190 | Fetal Doppler | Shenzhen AOJ Medical Technology Co., Ltd. | 2018-12-19 |
| K180419 | Ultrasonic Doppler (Model YM-2T8) | Shenzhen Imdk Medical Technology Co., Ltd. | 2018-07-19 |
| K172780 | SD1 Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2018-06-06 |
| K153475 | SD5 & SD6 Ultrasonic Tabletop Doppler | Edan Instruments, Inc. | 2016-01-29 |
| K140579 | ULTRASONIC POCKET DOPPLER | Edan Instruments, Inc. | 2015-02-06 |
Legacy Summary#
summary
FDA Review#
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