Suzhou Peaksonic Medical Technology Co., Ltd.
Manufacturer and brand owner in Suzhou, Jiangsu, China. 2 device types, 1 product catalogued, 2 clearances.
Suzhou Peaksonic Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Transducer, Ultrasonic, Diagnostic, System, Imaging, Pulsed Echo, Ultrasonic. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2019.
Registration
| Registered name | SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015972810 |
| FEI number | 3015972810 |
| DUNS | 554531949 |
| Establishment type | Manufacturer |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | 2A, West Side of Building G4, Kunshan Hi-Tech Medical Device Industrial Park |
| Postal code | 215341 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | Class 2 | Bladder Scanner M3, M3-HD, M4, M4-HD, Bladder Scanner, Model Name: M5, M5 Lite, Bladder Scanner (Models: M2, M2-W, M1, M1-W), Portable Blader Scanner 259-M2 | 2019 | 37 |
| Transducer, Ultrasonic, Diagnostic | Class 2 | Bladder Scanner M3, M3-HD, M4, M4-HD, Bladder Scanner, Model Name: M5, M5 Lite, Bladder Scanner (Models: M2, M2-W, M1, M1-W), Portable Blader Scanner 259-M2 | 2019 | 44 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Bladder Scanner | ITX | 8 |
Clearances
2 clearances name Suzhou Peaksonic Medical Technology Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K213488 | 2022-07-01 | IYO | Traditional | This company |
| K201316 | 2021-02-26 | IYO | Traditional | This company |
| K190769 | 2019-05-22 | IYO | Traditional | Suzhou Lischka Medtech Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2019 |
|---|---|
| Main products | Ultrasonic bladder scanners, Wireless transmission bladder scanners, Mobile bladder scanners |
| Export markets | Singapore and international |
Nearby Manufacturers
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.
The manufacturer named here can complete this record.