510(k) K900557

MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER by Monaghan Medical Corp. — Product Code CCQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1991
Date Received
February 7, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Device Class
Class I
Regulation Number
868.5640
Review Panel
AN
Submission Type