The following data is part of a premarket notification filed by Helax Ab with the FDA for Helax-visir.
Device ID | K972617 |
510k Number | K972617 |
Device Name: | HELAX-VISIR |
Classification | Accelerator, Linear, Medical |
Applicant | HELAX AB KLOSTERG. 12 Uppsala, SE S-75147 |
Contact | Jan Tornqvist |
Correspondent | Jan Tornqvist HELAX AB KLOSTERG. 12 Uppsala, SE S-75147 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-07-09 |
Decision Date | 1997-10-01 |
Summary: | summary |