510(k) K914251

MODEL IRC PASSPORT NEBULIZER by Invacare Corp. — Product Code LAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1992
Date Received
September 23, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Theophylline Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type