510(k) K151776
K151776 is an FDA 510(k) premarket notification submitted by Mespere Lifesciences, Inc. for the device "Central Venous Pressure System". The FDA issued a decision of Substantially Equivalent on August 12, 2015. 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 12, 2015
- Date Received
- July 1, 2015
- Clearance Type
- Special
- 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.