Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K837180Substantially Equivalent

Trephix Three Phse Generators and Exonon Single Phase Generators

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

K837180 is the FDA 510(k) clearance record for TREPHIX THREE PHSE GENERATORS AND EXONON SINGLE PHASE GENERATORS, 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 K837180.

Clearance record

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