McKesson
Doppler, Fetal Heart, Oled, W/ 3MHZ Probe
13manufacturers in China registered for this device type
18catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (10), Beijing (1), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Shenzhen Yuezhongxing Technology Co., Ltd. | Huizhou | Guangdong | Repacker / relabeller | 10 |
| Shenzhen Jumper Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 9 |
| Shenzhen Imdk Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Zhongshan Xiaolan Town Senlan Electronic Factory | Zhongshan | Guangdong | Manufacturer | 4 |
| Shenzhen Jamr Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
| Ninghai Guangjie Electronic Commerce Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 3 |
| Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
| Shenzhen Taikang Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
| Shenzhen Bestman Instrument Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Showing 12 of 13. All 13 manufacturers in China registered for Monitor, Ultrasonic, Fetal
Record
| Listed by | Mckesson Medical-Surgical Inc. |
|---|---|
| FDA product code | KNG |
| Device type | Monitor, Ultrasonic, Fetal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.2660 |
| 510(k) | K024197 |
| Record published | 2016-12-09 |
| Record revised | 2022-11-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1156 | In distribution | |
| 259-SD3F-3 | In distribution | |
| 259-SD3V-P5 | In distribution | |
| 1157 | In distribution | |
| 1154 | In distribution | |
| 1162 | In distribution | |
| 259-SD3V | In distribution | |
| 1155 | In distribution | |
| 259-SD3V-8 | In distribution | |
| 259-SD3V-5 | In distribution | |
| 259-SD3F-2 | In distribution | |
| 259-SD3V-P8 | In distribution | |
| 259-SD3F | In distribution | |
| 259-SD3F-P2 | In distribution | |
| 1163 | In distribution | |
| 259-SD3V-4 | In distribution | |
| 259-SD3V-P4 | In distribution | |
| 259-SD3F-P3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dopplex | Huntleigh Healthcare Ltd. | 30 |
| Vcomin Fetal Doppler | Vcomin Technlogy Limited | 27 |
| Summit Doppler | Coopersurgical, Inc. | 25 |
| MediChoice | Coopersurgical, Inc. | 21 |
| Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 20 |
| ClearTone Doppler | Coopersurgical, Inc. | 16 |
| fetal doppler | Shenzhen Jumper Medical Equipment Co., Ltd. | 11 |
| Contec | Contec Medical Systems Co., Ltd. | 10 |
| Monitor, Ultrasonic, Fetal | Edan Instruments, Inc. | 6 |
| FaceLake | Lorte Technologies, Inc | 6 |
| Natus Neurology | Natus Neurology Incorporated | 5 |
| Ultrasonic TableTop Doppler | Edan Instruments, Inc. | 4 |
Showing 12 of 69. All products under Monitor, Ultrasonic, Fetal
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Coopersurgical, Inc. | 510(k) number | 2017-10-06 | Class II | Error in labeling | The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe | 13 units | 2020-02-06 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.