510(k) K061456

A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR by A&D Engineering, Inc. — Product Code DXN

K061456 is an FDA 510(k) premarket notification submitted by A&D Engineering, Inc. for the device "A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR". The FDA issued a decision of Substantially Equivalent on June 21, 2006. 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
June 21, 2006
Date Received
May 25, 2006
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