Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K837111Substantially Equivalent

X Ray Tube Housing/insert

Atlantic Imaging Corp., Woburn MA / Traditional, Substantially Equivalent

K837111 is the FDA 510(k) clearance record for X RAY TUBE HOUSING/INSERT, cleared for Atlantic Imaging Corp. on . FDA records list one 510(k) clearance for Atlantic Imaging Corp. As of , FDA records show no recalls naming K837111.

Clearance record

Decision date
Received
(72 days to decision)
Review panel
Unknown
Applicant
Atlantic Imaging Corp. 21 Everett St., Woburn MA
Third party review
No