510(k) K132709
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