The following data is part of a premarket notification filed by Aktina Medical Physics Corp. with the FDA for Velos Constancy Check Device, Model 55-145.
| Device ID | K970384 |
| 510k Number | K970384 |
| Device Name: | VELOS CONSTANCY CHECK DEVICE, MODEL 55-145 |
| Classification | Accelerator, Linear, Medical |
| Applicant | AKTINA MEDICAL PHYSICS CORP. 360 NORTH ROUTE 9W Congers, NY 10920 |
| Contact | Joan Zacharopoulos |
| Correspondent | Joan Zacharopoulos AKTINA MEDICAL PHYSICS CORP. 360 NORTH ROUTE 9W Congers, NY 10920 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-03 |
| Decision Date | 1997-07-29 |
| Summary: | summary |