Eum 100PRO
FDA 510(k) K131889 · Promedic, Inc.
510(k) numberK131889
Submission
- Device name
- Eum 100PRO
- Applicant
- Promedic, Inc.
Bonita Springs, FL, US - Received
- June 25, 2013
- Decision date
- April 23, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OSP – Uterine Electromyographic Monitor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2720
- Specialty
- Obstetrics/Gynecology
The uterine electromyographic monitor is intended to pick up uterine emg signals from surface electrodes placed on the maternal abdomen. It produces a uterine activity tracing and monitors women in labor at term gestation with a singleton pregnancy.
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| K090145 | Surecall Emg Labor MonitorOSP · Traditional | Reproductive Research Technologies, LP | 01/25/2011SE |
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Questions and answers
When was Eum 100PRO cleared by the FDA?
Eum 100PRO (K131889) received a 510(k) decision of Substantially Equivalent on April 23, 2014, 302 days after the submission was received.
What is the product code of K131889?
The FDA product code is OSP – Uterine Electromyographic Monitor, a Class II (moderate risk) device regulated under 21 CFR 884.2720.