AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSFUSTION SYS
Device Facts
| Record ID | K944232 |
|---|---|
| Device Name | AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSFUSTION SYS |
| Applicant | Haemonetics Corp. |
| Product Code | CAC · Anesthesiology |
| Decision Date | Jul 20, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5830 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.