510(k) K082734

A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR by A&D Engineering, Inc. — Product Code DXN

K082734 is an FDA 510(k) premarket notification submitted by A&D Engineering, Inc. for the device "A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR". The FDA issued a decision of Substantially Equivalent on November 13, 2008. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. A&D Engineering, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2008
Date Received
September 18, 2008
Clearance Type
Special
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