Panels › Obstetrics/Gynecology › Product code OSP · Class 2
Uterine Electromyographic Monitor
Regulation 884.2720
0510(k)s in 12 months (10 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in OSP
| Company | 510(k)s | Recalls |
|---|---|---|
| Monica Healthcare | 4 | 1 |
| GE Healthcare, LLC | 0 | 2 |
| Obmedical Company | 2 | 0 |
| Reproductive Research Technologies, LP | 2 | 0 |
| Nemo Healthcare BV | 1 | 0 |
| Promedic, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 14, 2018 | GE Healthcare, LLC 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 wirele Terminated |
OSP | K112163 |
| 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 | K140862 |
| 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 | K140862 |
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