Central Venous Pressure System - Mespere Venus 1000

FDA 510(k) K131085 · Mespere Lifesciences, Inc.

Substantially Equivalent

510(k) numberK131085

Submission

Device name
Central Venous Pressure System - Mespere Venus 1000
Applicant
Mespere Lifesciences, Inc.
Waterloo, On, CA
Received
April 18, 2013
Decision date
August 22, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PFA – Non-Invasive Central Venous Manometer
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1140
Specialty
Cardiovascular

Measures the central venous blood pressure (CVP) non-invasively at the superior vena cava (right heart) based on near infrared spectroscopy (NIRS) technology.

Other 510(k)s with product code PFA

510(k)DeviceApplicantDecision
K151776Central Venous Pressure SystemPFA · Special Mespere Lifesciences, Inc.08/12/2015SE

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K151776Central Venous Pressure SystemPFA · Special 08/12/2015SE

Questions and answers

When was Central Venous Pressure System - Mespere Venus 1000 cleared by the FDA?

Central Venous Pressure System - Mespere Venus 1000 (K131085) received a 510(k) decision of Substantially Equivalent on August 22, 2013, 126 days after the submission was received.

What is the product code of K131085?

The FDA product code is PFA – Non-Invasive Central Venous Manometer, a Class II (moderate risk) device regulated under 21 CFR 870.1140.