510(k) K991355

METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE by Instrumentation Industries, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2000
Date Received
April 19, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type