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510(k) K142769

Fetal Doppler by Icare Newlife Technologies, Inc. — Product Code HEK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2015
Date Received
September 25, 2014
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 for product code HEK

  • K060410 — ECHOHEART TRANSVAGINAL DOPPLER PROBE (April 10, 2006)
  • 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)