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510(k) K780487

FETAL MONITORING SYSTEM by Sonicaid, Inc. — Product Code HFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1978
Date Received
March 27, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Pressure, Intrauterine
Device Class
Class II
Regulation Number
884.2700
Review Panel
OB
Submission Type

Other clearances by Sonicaid, Inc.

  • K873673 — BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONAL (February 26, 1988)
  • K872074 — 5 MHZ TRANSDUCER (August 25, 1987)
  • K863803 — VASOPULSE(TM)/MODEL 5000 (May 6, 1987)
  • K862720 — VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES (November 17, 1986)
  • K861237 — VASOVIEW DUPLEX IMAGING SYSTEM (July 14, 1986)
  • K851102 — VASOSCREEN IMPEDANCE PLETHYSMOGRAPH (May 16, 1985)
  • K833902 — VASOSCAN (January 27, 1984)
  • K832374 — PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH (December 1, 1983)
  • K833488 — SONICOMP (November 28, 1983)
  • K833227 — SONICAID MODEL D206E AIR EMBOLI-DETECT (October 27, 1983)

Other clearances for product code HFO

  • K973850 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007 (November 12, 1997)
  • K943989 — LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT (September 12, 1994)
  • K791633 — UC-2000 UTERINE CATHERIZATION SYSTEM (September 17, 1979)