510(k) K131023
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