510(k) K131889
- Device
- EUM 100PRO
- Applicant
- PROMEDIC, INC.
- 510(k) number
- K131889
- Product code
- OSP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-04-23
- Date received
- 2013-06-25
- Regulation
- 884.2720
- Classification name
- Uterine Electromyographic Monitor
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL DRYDEN
- Address
- 24301 Woodsage Dr. Bonita Springs FL US 34134 34134
FDA Registration Numbers#
- 3007607999
- 3007048259
- 1930027
- 1218950
- 3016618143
- 9610816
- 3007734888
- 3008729547
- 3014220748
- 3036470679
Source Documents#
Other 510(k) Records For Product Code OSP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K190798 | LaborView™ LV1000 Wireless Electrode System | Obmedical Company | 2020-09-18 |
| K153262 | PUREtrace™ | Nemo Healthcare BV | 2017-02-07 |
| K142583 | LaborView LV1000 | Obmedical Company | 2015-01-16 |
| K140862 | MONICA NOVII WIRELESS PATCH SYSTEM | Monica Healthcare, Ltd. | 2014-08-27 |
| K130002 | SURECALL LABOR MONITOR | Reproductive Research Technologies, LP | 2013-06-28 |
| K112390 | MONICA AN24 | Monica Healthcare, Ltd. | 2012-07-13 |
| K112163 | MONICA IF24 | Monica Healthcare | 2011-08-30 |
| K101801 | MONICA AN24 | Monica Healthcare | 2011-02-03 |
| K090145 | SURECALL EMG LABOR MONITOR | Reproductive Research Technologies, LP | 2011-01-25 |
Legacy Summary#
summary
FDA Review#
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