510(k) K140862 ยท OSP Uterine Electromyographic Monitor
MONICA NOVII WIRELESS PATCH SYSTEM
| Applicant | Monica Healthcare, Ltd., Nottingham, GB |
| Decision | Substantially Equivalent, Aug 27, 2014 |
| Received | Apr 3, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140862
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 14, 2018 | GE Healthcare, LLC 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 Terminated |
OSP | None listed |
| May 25, 2017 | MONICA HEALTHCARE LTD 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 Terminated |
OSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.