The following data is part of a premarket notification filed by Daxor Corporation with the FDA for Daxor Max100 Syringe (max100).
| Device ID | K970419 |
| 510k Number | K970419 |
| Device Name: | DAXOR MAX100 SYRINGE (MAX100) |
| Classification | Syringe, Piston |
| Applicant | DAXOR CORPORATION 312 TROSSACHS LN. Knoxville, TN 37922 -3421 |
| Contact | Ronald H Baldry |
| Correspondent | Ronald H Baldry DAXOR CORPORATION 312 TROSSACHS LN. Knoxville, TN 37922 -3421 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-04 |
| Decision Date | 1997-12-22 |