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510(k) K060820

CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060 by Suntech Medical, Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2006
Date Received
March 27, 2006
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

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  • K051904 — ALL PURPOSE CUFF, MODEL 222APC (September 9, 2005)

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