510(k) K961894

MDI TUTOR by Mdi Tutor, Inc. — Product Code CCQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1996
Date Received
May 16, 1996
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