510(k) K092031

VAPOR-CLEAR, MODEL 100 by Axon Medical, Inc. — Product Code CBN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2010
Date Received
July 6, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Gas-Scavenging
Device Class
Class II
Regulation Number
868.5430
Review Panel
AN
Submission Type