510(k) K251087
- Device
- Blood Volume Analyzer (200)
- Applicant
- Daxor Corporation
- 510(k) number
- K251087
- Product code
- JWO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-04
- Date received
- 2025-04-09
- Regulation
- 864.5950
- Classification name
- Device, Blood Volume Measuring
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jonathan Feldschuh
- Address
- 107 Meco Ln. Oak Ridge TN US 37830 37830
FDA Registration Numbers#
- 3003529145
Source Documents#
Other 510(k) Records For Product Code JWO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K964406 | AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER | Daxor Corporation | 1997-09-25 |