EUM 100PRO
FDA 510(k) clearance K131889 · decided 2014-04-23
Clearance details
- K-number
- K131889
- Device name
- EUM 100PRO
- Applicant
- Promedic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-06-25
- Decision date
- 2014-04-23
- Days to decision
- 302 days
- Clearance type
- Traditional
- Product code
- OSP
- Device class
- 2
- Regulation number
- 884.2720
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Bonita Springs, FL, US
- Third-party review
- No
- Expedited review
- No
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| 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.