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510(k) K063600

VISTA AVS by Summit Doppler Systems, Inc. — Product Code JAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2006
Date Received
December 4, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Monitor, Ultrasonic, Nonfetal
Device Class
Class II
Regulation Number
892.1540
Review Panel
RA
Submission Type

Other clearances by Summit Doppler Systems, Inc.

  • K103693 — VANTAGE ABI (February 15, 2011)
  • K101816 — STN PROBE (August 19, 2010)
  • K093393 — LIFEDOP MODEL 300ABI (December 24, 2009)
  • K090499 — LIFEDOP MODEL, L350R (March 31, 2009)
  • K060410 — ECHOHEART TRANSVAGINAL DOPPLER PROBE (April 10, 2006)
  • K024197 — LIFEDOP DOPPLER (January 3, 2003)

Other clearances for product code JAF

  • K242487 — Laminar P1 (LDH-HW-001) (December 13, 2024)
  • K141657 — THD REVOLUTION (February 24, 2015)
  • K110628 — SIMPLEABI (May 12, 2011)
  • K093393 — LIFEDOP MODEL 300ABI (December 24, 2009)
  • K090009 — THD SLIDE ONE (January 28, 2009)
  • K081429 — THD SLIDE (July 30, 2008)
  • K070815 — THD (June 20, 2007)
  • K060064 — STETHOFLUX (April 10, 2006)
  • K052067 — DOPPLER GUIDED PROCTOSCOPE, MODEL 500H (August 29, 2005)
  • K010521 — NICOLET VERSALAB (March 9, 2001)