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510(k) K883334

BIODOP(TM) by Diagnosis Related Systems, Inc. — Product Code HEK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1988
Date Received
August 9, 1988
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

  • K142769 — Fetal Doppler (March 20, 2015)
  • K060410 — ECHOHEART TRANSVAGINAL DOPPLER PROBE (April 10, 2006)
  • K902190 — FETAL PULSE DETECTOR MODEL DOP-1 (October 22, 1990)
  • K771211 — DOPPLER (UTD-5 & UTD-6) (July 14, 1977)