Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K837097Substantially Equivalent

2D Cardiac Sector Scanner

Second Foundation, Inc., Rancho Cordova CA / Traditional, Substantially Equivalent

K837097 is the FDA 510(k) clearance record for 2D CARDIAC SECTOR SCANNER, cleared for Second Foundation, Inc. on . FDA records list one 510(k) clearance for Second Foundation, Inc. As of , FDA records show no recalls naming K837097.

Clearance record

Decision date
Received
(55 days to decision)
Review panel
Unknown
Applicant
Second Foundation, Inc. 11093 Sun Center Dr., Rancho Cordova CA
Third party review
No