510(k) K132709

VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER by Vr Medical — Product Code CAH

K132709 is an FDA 510(k) premarket notification submitted by Vr Medical for the device "VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER". The FDA issued a decision of Substantially Equivalent on July 30, 2014. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Vr Medical has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2014
Date Received
August 29, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type