Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K837142Substantially Equivalent

Transducers Models 421, 419 and 420 for Irex System

Hoffrel Instruments, Inc., South Norwalk CT / Traditional, Substantially Equivalent

K837142 is the FDA 510(k) clearance record for TRANSDUCERS MODELS 421, 419 AND 420 FOR IREX SYSTEM, cleared for Hoffrel Instruments, Inc. on . FDA records list 12 510(k) clearances for Hoffrel Instruments, Inc., from to . As of , FDA records show no recalls naming K837142.

Clearance record

Decision date
Received
(79 days to decision)
Review panel
Unknown
Applicant
Hoffrel Instruments, Inc. 345 Wilson Ave., South Norwalk CT
Third party review
No