Sentech Korea Corp.
Country not established FDA
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Sentech Korea Corp. makes
Sentech Korea Corp. manufactures breath alcohol test systems, including models AL 2500, AL-5000, and AL-6000, designed for measuring blood alcohol concentration through exhaled breath.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Breath Alcohol Test System, Model Al 2500 Ref K053332
Regimes: 510(k) Registry: 510(k)Breath Alcohol Test System, Model Al-5000 Ref K061922
Regimes: 510(k) Registry: 510(k)Breath Alcohol Test System, Model Al-6000 Ref K060343
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Sentech Korea Corp. PAJU-SI Gyeonggi · KR FEI 3003383868
Frequently asked questions
How many devices does Sentech Korea Corp. have in the registry?
The registry currently lists 3 devices for Sentech Korea Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sentech Korea Corp.'s devices?
Among its 3 most recently registered devices, Sentech Korea Corp. has devices listed in FDA 510(k) (3 devices).
What risk classes do Sentech Korea Corp.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Sentech Korea Corp.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Sentech Korea Corp. in the registry?
The most recently registered devices listed for Sentech Korea Corp. include BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500, BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000 and BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000.
Which FDA establishments are linked to Sentech Korea Corp.?
1 FDA establishment is linked to Sentech Korea Corp. in the registry; they are listed on the company page.