Uterine Electromyographic Monitor
The Uterine Electromyographic Monitor (product code OSP) is an obstetric monitoring device that detects uterine electromyographic (EMG) signals from surface electrodes placed on the maternal abdomen. It produces a uterine activity tracing for monitoring women in labor at term gestation with a singleton pregnancy. As an FDA Class 2 device under regulation 884.2720, it requires 510(k) premarket clearance and falls within the Obstetrics/Gynecology specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OSP
- Device Class
- FDA class 2
- Regulation Number
- 884.2720
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K190798 | LaborView LV1000 Wireless Electrode System | Sep 18, 2020 | Substantially Equivalent | Obmedical Company |
| K153262 | PUREtrace | Feb 07, 2017 | Substantially Equivalent | Nemo Healthcare BV |
| K142583 | LaborView LV1000 | Jan 16, 2015 | Substantially Equivalent | Obmedical Company |
| K140862 | MONICA NOVII WIRELESS PATCH SYSTEM | Aug 27, 2014 | Substantially Equivalent | Monica Healthcare, Ltd. |
| K131889 | EUM 100PRO | Apr 23, 2014 | Substantially Equivalent | Promedic, Inc. |
| K130002 | SURECALL LABOR MONITOR | Jun 28, 2013 | Substantially Equivalent | Reproductive Research Technologies, LP |
| K112390 | MONICA AN24 | Jul 13, 2012 | Substantially Equivalent | Monica Healthcare, Ltd. |
| K112163 | MONICA IF24 | Aug 30, 2011 | Substantially Equivalent | Monica Healthcare |
| K101801 | MONICA AN24 | Feb 03, 2011 | Substantially Equivalent | Monica Healthcare |
| K090145 | SURECALL EMG LABOR MONITOR | Jan 25, 2011 | Substantially Equivalent | Reproductive Research Technologies, LP |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.