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510(k) K093393

LIFEDOP MODEL 300ABI by Summit Doppler Systems, Inc. — Product Code JAF

K093393 is an FDA 510(k) premarket notification submitted by Summit Doppler Systems, Inc. for the device "LIFEDOP MODEL 300ABI". The FDA issued a decision of Substantially Equivalent on December 24, 2009. The device falls under product code JAF (Monitor, Ultrasonic, Nonfetal), a Class II device regulated under 21 CFR 892.1540. Summit Doppler Systems, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 2009
Date Received
October 30, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • 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)

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)
  • K090009 — THD SLIDE ONE (January 28, 2009)
  • K081429 — THD SLIDE (July 30, 2008)
  • K070815 — THD (June 20, 2007)
  • K063600 — VISTA AVS (December 19, 2006)
  • K060064 — STETHOFLUX (April 10, 2006)
  • K052067 — DOPPLER GUIDED PROCTOSCOPE, MODEL 500H (August 29, 2005)
  • K010521 — NICOLET VERSALAB (March 9, 2001)

FDA data resources