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510(k) K053209

TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM by Suntech Medical, Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2006
Date Received
November 16, 2005
Clearance Type
Traditional
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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  • K151520 — Oscar 2 (February 19, 2016)
  • K122401 — TANGO M2 BLOOD PRESSURE MONITOR (November 2, 2012)
  • K080854 — DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100 (October 20, 2008)
  • K070750 — 247 BP DEVICE (May 2, 2007)
  • K060820 — CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060 (June 7, 2006)
  • K051904 — ALL PURPOSE CUFF, MODEL 222APC (September 9, 2005)

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