510(k) K102624

AVITA WRIST TYPE BLOOD PRESSURE MONITOR by Avita Corporation — Product Code DXN

K102624 is an FDA 510(k) premarket notification submitted by Avita Corporation for the device "AVITA WRIST TYPE BLOOD PRESSURE MONITOR". The FDA issued a decision of Substantially Equivalent on December 16, 2010. 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 16, 2010
Date Received
September 13, 2010
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