510(k) K072137

AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZB by Avita Corporation — Product Code DXN

K072137 is an FDA 510(k) premarket notification submitted by Avita Corporation for the device "AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZB". The FDA issued a decision of Substantially Equivalent on December 7, 2007. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Avita Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2007
Date Received
August 2, 2007
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