Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K851695Substantially Equivalent

Ultra-Neb 100 Ultrasonic Nebulizer

The Devilbiss Co., Somerset PA / Traditional, Substantially Equivalent

K851695 is the FDA 510(k) clearance record for ULTRA-NEB 100 ULTRASONIC NEBULIZER, cleared for The Devilbiss Co. on . FDA records list 12 510(k) clearances for The Devilbiss Co., from to . As of , FDA records show no recalls naming K851695.

Clearance record

Decision date
Received
(44 days to decision)
Review panel
Unknown
Applicant
The Devilbiss Co. P.O. Box 635, Somerset PA
Third party review
No