510(k) K091414

VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH by Biocare Corp. — Product Code DXN

K091414 is an FDA 510(k) premarket notification submitted by Biocare Corp. for the device "VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH". The FDA issued a decision of Substantially Equivalent on October 21, 2009. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Biocare Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2009
Date Received
May 13, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type