Home / 510(k) Clearances / K792669

510(k) K792669

COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE by Ge Medical Systems Information Technologies — Product Code HGP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1980
Date Received
December 27, 1979
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 Ge Medical Systems Information Technologies

  • K251670 — MAC 7 Resting ECG Analysis System (January 26, 2026)
  • K242562 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (July 9, 2025)
  • K243540 — Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client (December 12, 2024)
  • K233810 — Portrait VSM (April 25, 2024)
  • K234130 — Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer A (March 20, 2024)
  • K231870 — CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System (December 13, 2023)
  • K230626 — Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (August 11, 2023)
  • K230145 — ONE-CUF (March 14, 2023)
  • K222586 — Mural Clinical Viewer (December 21, 2022)
  • K221904 — EK12 V2 Algorithm (December 20, 2022)

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)