Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K830253Substantially Equivalent

End Tidal CO2 Analyzer #411

Andros Incorporated, Walker MI / Traditional, Substantially Equivalent

K830253 is the FDA 510(k) clearance record for END TIDAL CO2 ANALYZER #411, cleared for Andros Incorporated on . FDA records list one 510(k) clearance for Andros Incorporated. As of , FDA records show no recalls naming K830253.

Clearance record

Decision date
Received
(65 days to decision)
Review panel
Unknown
Applicant
Andros Incorporated 4221 Richmond Rd., NW, Walker MI
Third party review
No