NON STRESS TEST MONITOR 507
Device Facts
| Record ID | K840285 |
|---|---|
| Device Name | NON STRESS TEST MONITOR 507 |
| Applicant | Imex Medical Systems, Inc. |
| Product Code | HGH · Obstetrics/Gynecology |
| Decision Date | May 9, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5070 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A vacuum abortion system is a device designed to aspirate transcervically the products of conception or menstruation from the uterus by using a cannula connected to a suction source. This device is used for pregnancy termination or menstrual regulation. This type of device may include aspiration cannula, vacuum source, and vacuum controller.