510(k) K142149

OXYTOTE INFINITY SERIES VIPR SYSTEMS by Western/Scott Fetzer Co. — Product Code ECX

K142149 is an FDA 510(k) premarket notification submitted by Western/Scott Fetzer Co. for the device "OXYTOTE INFINITY SERIES VIPR SYSTEMS". The FDA issued a decision of Substantially Equivalent on April 17, 2015. The device falls under product code ECX (Cylinder, Compressed Gas, And Valve), a Class I device regulated under 21 CFR 868.2700.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2015
Date Received
August 5, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cylinder, Compressed Gas, And Valve
Device Class
Class I
Regulation Number
868.2700
Review Panel
AN
Submission Type