510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K820199Substantially Equivalent

Fetalscreen

Ortho Diagnostic Systems, Inc., Carpinteria CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820199 is the FDA 510(k) clearance record for FETALSCREEN, cleared for Ortho Diagnostic Systems, Inc. on . FDA records list 126 510(k) clearances for Ortho Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K820199.

Clearance record

Decision date
Received
(106 days to decision)
Review panel
Unknown
Applicant
Ortho Diagnostic Systems, Inc. 125 Mark Ave., Carpinteria CA
Third party review
No