510(k) K261099
K261099 is an FDA 510(k) premarket notification submitted by Daxor Corporation for the device "Blood Volume Analyzer (200)". The FDA issued a decision of Substantially Equivalent on June 18, 2026. The device falls under product code JWO (Device, Blood Volume Measuring), a Class II device regulated under 21 CFR 864.5950. Daxor Corporation has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 18, 2026
- Date Received
- April 2, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Blood Volume Measuring
- Device Class
- Class II
- Regulation Number
- 864.5950
- Review Panel
- HE
- Submission Type