MONICA AN24
FDA 510(k) clearance K112390 · decided 2012-07-13
Clearance details
- K-number
- K112390
- Device name
- MONICA AN24
- Applicant
- Monica Healthcare, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-08-18
- Decision date
- 2012-07-13
- Days to decision
- 330 days
- Clearance type
- Traditional
- Product code
- OSP
- Device class
- 2
- Regulation number
- 884.2720
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Nottingham, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LaborView™ LV1000 Wireless Electrode System (K190798) | Obmedical Company | 2020-09-18 |
| PUREtrace™ (K153262) | Nemo Healthcare BV | 2017-02-07 |
| LaborView LV1000 (K142583) | Obmedical Company | 2015-01-16 |
| MONICA NOVII WIRELESS PATCH SYSTEM (K140862) | Monica Healthcare, Ltd. | 2014-08-27 |
| EUM 100PRO (K131889) | Promedic, Inc. | 2014-04-23 |
| SURECALL LABOR MONITOR (K130002) | Reproductive Research Technologies, LP | 2013-06-28 |
| MONICA IF24 (K112163) | Monica Healthcare | 2011-08-30 |
| MONICA AN24 (K101801) | Monica Healthcare | 2011-02-03 |
| SURECALL EMG LABOR MONITOR (K090145) | Reproductive Research Technologies, LP | 2011-01-25 |
Recalls involving this device
No recalls on record reference this clearance.