The following data is part of a premarket notification filed by Aktina Medical Physics Corp. with the FDA for Stereotactic Head And Neck Localizer, Model 50-100.
Device ID | K081935 |
510k Number | K081935 |
Device Name: | STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100 |
Classification | Accelerator, Linear, Medical |
Applicant | AKTINA MEDICAL PHYSICS CORP. 360 NORTH ROUTE 9W Congers, NY 10920 |
Contact | Tony Spaccarotella |
Correspondent | Tony Spaccarotella 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 | 2008-07-07 |
Decision Date | 2008-10-07 |
Summary: | summary |