510(k) K914273

A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR by A&D Engineering, Inc. — Product Code DSK

K914273 is an FDA 510(k) premarket notification submitted by A&D Engineering, Inc. for the device "A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR". The FDA issued a decision of Substantially Equivalent on February 9, 1993. The device falls under product code DSK (Computer, Blood-Pressure), a Class II device regulated under 21 CFR 870.1110. A&D Engineering, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1993
Date Received
September 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Blood-Pressure
Device Class
Class II
Regulation Number
870.1110
Review Panel
CV
Submission Type