Blood Volume Analyzer (200)
Device Facts
| Record ID | K261099 |
|---|---|
| Device Name | Blood Volume Analyzer (200) |
| Applicant | Daxor Corporation |
| Product Code | JWO · Hematology |
| Decision Date | Jun 18, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 864.5950 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A blood volume measuring device is a manual, semiautomated, or automated system that is used to calculate the red cell mass, plasma volume, and total blood volume.
