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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K837355Substantially Equivalent

Unknown

Elscint, Inc., Hackensack NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K837355 is the FDA 510(k) clearance record for UNKNOWN, cleared for Elscint, Inc. on . FDA records list 94 510(k) clearances for Elscint, Inc., from to . As of , FDA records show no recalls naming K837355.

Clearance record

Decision date
Received
(56 days to decision)
Review panel
Unknown
Applicant
Elscint, Inc. 505 Main St., Hackensack NJ
Third party review
No