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510(k) K122401

TANGO M2 BLOOD PRESSURE MONITOR by Suntech Medical, Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2012
Date Received
August 7, 2012
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

Other clearances by Suntech Medical, Inc.

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  • K070750 — 247 BP DEVICE (May 2, 2007)
  • K060820 — CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060 (June 7, 2006)
  • K053209 — TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM (January 5, 2006)
  • K051904 — ALL PURPOSE CUFF, MODEL 222APC (September 9, 2005)

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