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510(k) K872057

FETAL SCALP ELECTRODE by Medical Accessories, Inc. — Product Code HGP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1987
Date Received
May 28, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Circular (Spiral), Scalp And Applicator
Device Class
Class II
Regulation Number
884.2675
Review Panel
OB
Submission Type

Other clearances by Medical Accessories, Inc.

  • K920056 — POCKET SIZE FETAL HEART DETECTOR (December 11, 1992)
  • K901152 — REDYPLATE DISPOSABLE LEG PLATE (April 4, 1990)

Other clearances for product code HGP

  • K243291 — Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) (January 17, 2025)
  • K030691 — FETAL SPIRAL ELECTRODE, MODEL FSE07000 (September 17, 2003)
  • K003458 — SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 (May 3, 2001)
  • K943732 — LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE (October 20, 1994)
  • K910815 — CR SPIRAL ELECTRODE (December 10, 1991)
  • K911657 — FETAL SCALP SPIRAL ELECTRODE (July 11, 1991)
  • K905830 — COMBO FETAL SCALP ELECTRODE/LEGPLATE (March 29, 1991)
  • K904745 — MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE (January 29, 1991)
  • K905130 — FETAL MONITORING SPIRAL ELECTRODE (January 29, 1991)
  • K901152 — REDYPLATE DISPOSABLE LEG PLATE (April 4, 1990)