510(k) K062342

TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT by Sentra Medical Devices, LLC — Product Code DRS

K062342 is an FDA 510(k) premarket notification submitted by Sentra Medical Devices, LLC for the device "TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT". The FDA issued a decision of Substantially Equivalent on September 25, 2006. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850.