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510(k) K010828

DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP by A&D Engineering, Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2001
Date Received
March 20, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

Other clearances by A&D Engineering, Inc.

  • K082734 — A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR (November 13, 2008)
  • K062027 — A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR (January 19, 2007)
  • K061456 — A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR (June 21, 2006)
  • K043217 — A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR (March 3, 2005)
  • K042967 — A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512 (December 3, 2004)
  • K040371 — A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR (May 19, 2004)
  • K040229 — A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328 (March 19, 2004)
  • K032499 — A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS (October 30, 2003)
  • K012472 — A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONIT (February 15, 2002)
  • K012013 — LIFESOURCE MODELS UA-787, UA 787PC, UA-787T (July 13, 2001)

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