510(k) K131085
K131085 is an FDA 510(k) premarket notification submitted by Mespere Lifesciences, Inc. for the device "CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000". The FDA issued a decision of Substantially Equivalent on August 22, 2013. The device falls under product code PFA (Non-Invasive Central Venous Manometer), a Class II device regulated under 21 CFR 870.1140. Mespere Lifesciences, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 2013
- Date Received
- April 18, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Non-Invasive Central Venous Manometer
- Device Class
- Class II
- Regulation Number
- 870.1140
- Review Panel
- CV
- Submission Type
Measures the central venous blood pressure (CVP) non-invasively at the superior vena cava (right heart) based on near infrared spectroscopy (NIRS) technology.