Tria II Display Doppler
With 2.0 MHz Waterproof Obstetrical Probe
13manufacturers in China registered for this device type
3catalogue numbers in this listing
1recall
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 | Coopersurgical, Inc., United States |
|---|---|
| FDA product code | KNG |
| Device type | Monitor, Ultrasonic, Fetal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.2660 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K024197 |
| Record published | 2016-03-31 |
| Record revised | 2024-02-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T345-D | In distribution | |
| T334-D | In distribution | |
| T336-D | 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 |
| McKesson | Mckesson Medical-Surgical Inc. | 18 |
| 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 |
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.