Monica Healthcare
Nottingham, GB
Monica Healthcare appears in FDA device records in Nottingham, GB. FDA records list 4 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Monica Healthcare between 2011 and 2014. The busiest year on record is 2011, with 2. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 2 |
| 2012 | 1 |
| 2014 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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. | Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain