510(k) K964406
- Device
- AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER
- Applicant
- DAXOR CORPORATION
- 510(k) number
- K964406
- Product code
- JWO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-09-25
- Date received
- 1996-11-04
- Regulation
- 864.5950
- Classification name
- Device, Blood Volume Measuring
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOSEPH FELDSCHUH
- Address
- 350 Fifth Ave., Suite 7120 New York NY US 10118 10118
FDA Registration Numbers#
- 3003529145
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JWO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251087 | Blood Volume Analyzer (200) | Daxor Corporation | 2025-08-04 |
Legacy Summary#
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FDA Review#
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