MONICA IF24— 510(k) K112163

Substantially Equivalent

Monica Healthcare

FDA 510(k) clearance K112163 for MONICA IF24, Substantially Equivalent on 2011-08-30. Applicant: Monica Healthcare. Device class: 2.

Clearance details

Applicant: Monica Healthcare
Product code: Code OSP
Device class: Class 2
Regulation: 21 CFR 884.2720
Advisory panel: Obstetrics/Gynecology
Date received: 2011-07-27
Decision date: 2011-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nottingham, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code OSP

K190798 — LaborView LV1000 Wireless Electrode System2020-09-18
K153262 — PUREtrace2017-02-07
K142583 — LaborView LV10002015-01-16
K140862 — MONICA NOVII WIRELESS PATCH SYSTEM2014-08-27
K131889 — EUM 100PRO2014-04-23

More clearances from Monica Healthcare

K101801 — MONICA AN242011-02-03

Recalls naming K112163

K-number listed on FDA's recall record

Z-1293-2018 — Uterine Electromyographic Monitor -Monica IF24 Interface System Product Usage: The Monica IF24 CTG Interface Device is an accessory to the Monica AN24 which provides a means of interfacing the wireless output of the Monica AN24 to the transducer inputs of a CTG Fetal monitor. The Monica IF24 CTG Interface Device enables signals collected by the Monica AN24 to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected. The device is intended for use by healthcare professionals in a clinical setting.Class II·Terminated·GE Healthcare, LLC·20171215

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112163.

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