Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K837175Substantially Equivalent

Armex Ls-51

Elscint, Inc., Hackensack NJ / Traditional, Substantially Equivalent

K837175 is the FDA 510(k) clearance record for ARMEX LS-51, 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 K837175.

Clearance record

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