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
SUBSCRIBE / SIGN IN
K837178Substantially Equivalent

Standex System

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

K837178 is the FDA 510(k) clearance record for STANDEX SYSTEM, 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 K837178.

Clearance record

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