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510(k) K151520

Oscar 2 by Suntech Medical, Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2016
Date Received
June 5, 2015
Clearance Type
Abbreviated
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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