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510(k) K103693

VANTAGE ABI by Summit Doppler Systems, Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2011
Date Received
December 17, 2010
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 Summit Doppler Systems, Inc.

  • K101816 — STN PROBE (August 19, 2010)
  • K093393 — LIFEDOP MODEL 300ABI (December 24, 2009)
  • K090499 — LIFEDOP MODEL, L350R (March 31, 2009)
  • K063600 — VISTA AVS (December 19, 2006)
  • K060410 — ECHOHEART TRANSVAGINAL DOPPLER PROBE (April 10, 2006)
  • K024197 — LIFEDOP DOPPLER (January 3, 2003)

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