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510(k) K902190

FETAL PULSE DETECTOR MODEL DOP-1 by Advanced Medical Systems, Inc. — Product Code HEK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1990
Date Received
May 16, 1990
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 Advanced Medical Systems, Inc.

  • K955931 — MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION) (August 14, 1996)
  • K952031 — ULTRASOUND TRANSDUCER, MODEL US917 (July 18, 1995)
  • K940898 — MODEL IM77 INTRAPARTUM FETAL MONITOR (March 1, 1995)
  • K923335 — ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION (July 22, 1994)
  • K932278 — PFM PROFESSIONAL 7000 SPIROMETER (December 17, 1993)
  • K911657 — FETAL SCALP SPIRAL ELECTRODE (July 11, 1991)
  • K894568 — NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM (January 9, 1990)
  • K891672 — PUL-TRON 100K PROFESSIONAL SPIROMETER (June 16, 1989)
  • K880756 — MODEL PM-20A PHYSIOLOGICAL MONITOR (September 27, 1988)

Other clearances for product code HEK

  • K142769 — Fetal Doppler (March 20, 2015)
  • K060410 — ECHOHEART TRANSVAGINAL DOPPLER PROBE (April 10, 2006)
  • K883334 — BIODOP(TM) (December 15, 1988)
  • K771211 — DOPPLER (UTD-5 & UTD-6) (July 14, 1977)