V7 PORTABLE SUCTION UNITS
Device Facts
| Record ID | K093241 |
|---|---|
| Device Name | V7 PORTABLE SUCTION UNITS |
| Applicant | Hersill, S.L. |
| Product Code | BTA · General, Plastic Surgery |
| Decision Date | Apr 27, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4780 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Regulatory Classification
Identification
A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.