Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K827713Substantially Equivalent

Scanner 560 Ultrasound Scanner

Pie Data, Inc., Singer Island FL / Traditional, Substantially Equivalent

K827713 is the FDA 510(k) clearance record for SCANNER 560 ULTRASOUND SCANNER, cleared for Pie Data, Inc. on . FDA records list 2 510(k) clearances for Pie Data, Inc., from to . As of , FDA records show no recalls naming K827713.

Clearance record

Decision date
Received
(49 days to decision)
Review panel
Unknown
Applicant
Pie Data, Inc. 2655 N. Ocean Dr., Singer Island FL
Third party review
No