Comdek Industrial Corp.
TaiwanFDA applicant, unverified
- Devices
- 1
What Comdek Industrial Corp. makes
Comdek Industrial Corp. manufactures pulse oximeters, including a portable model (MD-600P), a traveler-specific design (MD-650P), and a palm-sized version (MD-680P). These devices measure oxygen saturation and pulse rate, primarily for non-clinical or point-of-care use.
The company’s pulse oximeters are classified as Class II devices under FDA regulations and are supported by 510(k) clearance records. The products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Comdek Industrial Corp. have in the registry?
The registry currently lists 1 device for Comdek Industrial Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Comdek Industrial Corp.'s devices?
Among its 1 most recently registered device, Comdek Industrial Corp. has devices listed in FDA 510(k) (1 device).
What risk classes do Comdek Industrial Corp.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Comdek Industrial Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Comdek Industrial Corp. in the registry?
The most recently registered devices listed for Comdek Industrial Corp. include PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P.