510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K860164Substantially Equivalent

2500 Printer

Datascope Corp., Paramus NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860164 is the FDA 510(k) clearance record for 2500 PRINTER, cleared for Datascope Corp. on . FDA records list 139 510(k) clearances for Datascope Corp., from to . As of , FDA records show no recalls naming K860164.

Clearance record

Decision date
Received
(139 days to decision)
Review panel
Unknown
Applicant
Datascope Corp. 580 Winters Ave., Paramus NJ
Third party review
No