510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K242272Substantially Equivalent

CORIOGRAPH Pre-Op Planning and Modeling Services

Blue Belt Technologies, Inc., Pittsburgh PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K242272 is the FDA 510(k) clearance record for CORIOGRAPH Pre-Op Planning and Modeling Services, cleared for Blue Belt Technologies, Inc. on . FDA records list 22 510(k) clearances for Blue Belt Technologies, Inc., from to . As of , FDA records show no recalls naming K242272.

Clearance record

Decision date
Received
(106 days to decision)
Review panel
Unknown
Applicant
Blue Belt Technologies, Inc. 2875 Railroad St., Pittsburgh PA
510(k) summary
Summary PDF
Third party review
No