LaborView LV1000
FDA 510(k) clearance K142583 · decided 2015-01-16
Clearance details
- K-number
- K142583
- Device name
- LaborView LV1000
- Applicant
- Obmedical Company
- Decision
- Substantially Equivalent
- Date received
- 2014-09-15
- Decision date
- 2015-01-16
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- OSP
- Device class
- 2
- Regulation number
- 884.2720
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Newberry, FL, US
- 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 |
| 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 AN24 (K112390) | Monica Healthcare, Ltd. | 2012-07-13 |
| 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.