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510(k) K060410

ECHOHEART TRANSVAGINAL DOPPLER PROBE by Summit Doppler Systems, Inc. — Product Code HEK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2006
Date Received
February 16, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Heart Sound, Fetal, Ultrasonic
Device Class
Class II
Regulation Number
884.2660
Review Panel
OB
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)
  • K063600 — VISTA AVS (December 19, 2006)
  • K024197 — LIFEDOP DOPPLER (January 3, 2003)

Other clearances for product code HEK

  • K142769 — Fetal Doppler (March 20, 2015)
  • K902190 — FETAL PULSE DETECTOR MODEL DOP-1 (October 22, 1990)
  • K883334 — BIODOP(TM) (December 15, 1988)
  • K771211 — DOPPLER (UTD-5 & UTD-6) (July 14, 1977)