Data / Medical devices / Taiwan / Aco Healthcare Co., Ltd.
Aco Healthcare Co., Ltd.: FDA-registered device maker in Taoyuan City, Taiwan, 1 510(k) clearance
Aco Healthcare Co., Ltd. is registered with the FDA (registration 3025786376) in Taoyuan City, Taiwan. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 24, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025786376
- Address
- 1F, No.8-1, Nandong Rd., Pingzhen Dist, Taoyuan City, Taiwan, 324
- Owner or operator
- Aco Healthcare Co., Ltd. (10089889)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- January 18, 2024
- Registered through
- 2026
- Brand names listed
- Aco Apache Ultrasound System (model: C62), Aco Apache Ultrasound System (model: L154), Aco Apache Ultrasound System (model: neo C62), Aco Apache Ultrasound System (model: neo L154), Aco Apache Ultrasound System (model: neo L187), Aco Apache Ultrasound System (model: neo P3H), Aco Apache Ultrasound System (model: neo P42), neo Medical Ultrasound System (model: neo C62) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 24, 2023 | K231509 | Aco Apache Ultrasound System | IYN | Substantially Equivalent | Aco Healthcare Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
Updated October 24, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.