510(k) K131023

THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN by Medical Products, LLC — Product Code NFB

K131023 is an FDA 510(k) premarket notification submitted by Medical Products, LLC for the device "THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN". The FDA issued a decision of Substantially Equivalent on October 11, 2013. The device falls under product code NFB (Conserver, Oxygen), a Class II device regulated under 21 CFR 868.5905. Medical Products, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2013
Date Received
April 12, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conserver, Oxygen
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type