510(k) K261099
- Device
- Blood Volume Analyzer (200)
- Applicant
- Daxor Corporation
- 510(k) number
- K261099
- Product code
- JWO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-18
- Date received
- 2026-04-02
- Regulation
- 864.5950
- Classification name
- Device, Blood Volume Measuring
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jonathan Feldschuh
- Address
- 107 Meco Ln. Oak Ridge TN US 37830 37830
FDA Registration Numbers#
- 3003529145