COMBO FETAL SCALP ELECTRODE/LEGPLATE— 510(k) K905830

Name: FDA 510(k) clearance K905830
Creator: U.S. Food and Drug Administration
Published: 1991-03-29

Substantially Equivalent

Utah Medical Products, Inc.

FDA 510(k) clearance K905830 for COMBO FETAL SCALP ELECTRODE/LEGPLATE, Substantially Equivalent on 1991-03-29. Applicant: Utah Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Utah Medical Products, Inc.
Product code: Code HGP
Device class: Class 2
Regulation: 21 CFR 884.2675
Advisory panel: Obstetrics/Gynecology
Date received: 1990-12-31
Decision date: 1991-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Midvale, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HGP

view all

K243291 — Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)2025-01-17
K030691 — FETAL SPIRAL ELECTRODE, MODEL FSE070002003-09-17
K003458 — SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-70002001-05-03
K943732 — LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE1994-10-20
K910815 — CR SPIRAL ELECTRODE1991-12-10

More clearances from Utah Medical Products, Inc.

view all

K143424 — UTAH CVX-RIPE2015-08-28
K123310 — FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)2013-01-23
K101535 — BT-CATH2011-01-11
K063611 — SALINE/ CONTRAST MEDIA INFUSION CATHETER2007-05-23
K001874 — PERIPHERALLY INSERTED CENTRAL CATHETER2000-09-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.