510(k) K874513

MONAGHAN AEROCHAMBER WITH MASK by Monaghan Medical Corp. — Product Code CCQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1987
Date Received
November 2, 1987
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