Compal Electronics, Inc.
TaiwanFDA applicant, unverified FDA
- Devices
- 5
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Compal Electronics, Inc. makes
Compal Electronics, Inc. manufactures radiofrequency ablation systems, such as the AblatePal, designed for targeted tissue ablation procedures. They also produce ultrasound imaging systems, including the Apache Ultrasound System (Model C62), used for diagnostic and procedural guidance. Additionally, the company supplies bilevel positive airway pressure devices, like the BreathePal Bilevel (GFM50-MD2201), for respiratory therapy.
These devices are classified under Class II by regulatory standards and are listed via the FDA’s 510(k) pathway. The company operates from the United States, adhering to domestic regulatory requirements for medical devices.
Catalogue
- Registry: GUDID
- Registry: GUDID
AblatePal Radiofrequency Ablation System Ref K223135
Regimes: 510(k) Registry: 510(k)Apache Ultrasound System (Model C62) Ref K202074
Regimes: 510(k) Registry: 510(k)BreathePal Bilevel (GFM50-MD2201) Ref K252078
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 656127743
FDA establishments
- Compal Electronics, Inc Taoyuan City · TW FEI 3012428212
Frequently asked questions
How many devices does Compal Electronics, Inc. have in the registry?
The registry currently lists 5 devices for Compal Electronics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Compal Electronics, Inc.'s devices?
Among its 5 most recently registered devices, Compal Electronics, Inc. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Compal Electronics, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Compal Electronics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Compal Electronics, Inc. in the registry?
The most recently registered devices listed for Compal Electronics, Inc. include AblatePal Radiofrequency Ablation System HFM01-MD2202, BreathePal Bilevel GFM50-MD2201, AblatePal Radiofrequency Ablation System and Apache Ultrasound System (Model C62).
Which FDA establishments are linked to Compal Electronics, Inc.?
1 FDA establishment is linked to Compal Electronics, Inc. in the registry; they are listed on the company page.