The following data is part of a premarket notification filed by Daxor Corporation with the FDA for Automated Multi-point Blood Volume Analyzer.
| Device ID | K964406 |
| 510k Number | K964406 |
| Device Name: | AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER |
| Classification | Device, Blood Volume Measuring |
| Applicant | DAXOR CORPORATION 350 FIFTH AVE., SUITE 7120 New York, NY 10118 |
| Contact | Joseph Feldschuh |
| Correspondent | Joseph Feldschuh DAXOR CORPORATION 350 FIFTH AVE., SUITE 7120 New York, NY 10118 |
| Product Code | JWO |
| CFR Regulation Number | 864.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-04 |
| Decision Date | 1997-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B641BVA100SOFTWARE60 | K964406 | 000 |