Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K828595Substantially Equivalent

Maxicamera 300A Small Field of View Imaging System

General Electric Co., Schenectady NY / Traditional, Substantially Equivalent

K828595 is the FDA 510(k) clearance record for MAXICAMERA 300A SMALL FIELD OF VIEW IMAGING SYSTEM, cleared for General Electric Co. on . FDA records list 256 510(k) clearances for General Electric Co., from to . As of , FDA records show no recalls naming K828595.

Clearance record

Decision date
Received
(49 days to decision)
Review panel
Unknown
Applicant
General Electric Co. 1 River Rd., Schenectady NY
Third party review
No