MONICA NOVII WIRELESS PATCH SYSTEM— 510(k) K140862
Substantially EquivalentMonica Healthcare, Ltd.
FDA 510(k) clearance K140862 for MONICA NOVII WIRELESS PATCH SYSTEM, Substantially Equivalent on 2014-08-27. Applicant: Monica Healthcare, Ltd.. Device class: 2.
Clearance details
- Applicant
- Monica Healthcare, Ltd.
- Product code
- Code OSP
- Device class
- Class 2
- Regulation
- 21 CFR 884.2720
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nottingham, GB
Recent devices under product code OSP
view allMore clearances from Monica Healthcare, Ltd.
view allRecalls naming K140862
K-number listed on FDA's recall record- Z-1292-2018 — Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor via three cables. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected.
- Z-2588-2017 — Monica Novii Wireless Patch System product Usage: Novii Interface - The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected. Novii Pod - The Monica Novii Pod is an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii Pod acquires and displays the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Novii Pod also acquires and displays the UA tracing from the uterine electromyography (EMG) signal and the MHR tracing from the maternal ECG signal (mECG). The Novii Pod is indicated for use on women who are at >36 completed weeks, in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140862.
Data sourced from openFDA. This site is unofficial and independent of the FDA.