510(k) K152980
K152980 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "Flo Trac sensor, Volume View sensor". The FDA issued a decision of Substantially Equivalent on January 19, 2016. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 19, 2016
- Date Received
- October 9, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Blood-Pressure, Extravascular
- Device Class
- Class II
- Regulation Number
- 870.2850
- Review Panel
- CV
- Submission Type