510(k) K043217

A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR by A&D Engineering, Inc. — Product Code DXN

K043217 is an FDA 510(k) premarket notification submitted by A&D Engineering, Inc. for the device "A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR". The FDA issued a decision of Substantially Equivalent on March 3, 2005. 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
March 3, 2005
Date Received
November 22, 2004
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