The following data is part of a premarket notification filed by Doseoptics Llc with the FDA for Beamsite.
Device ID | K212606 |
510k Number | K212606 |
Device Name: | BeamSite |
Classification | Accelerator, Linear, Medical |
Applicant | DoseOptics LLC 16 Cavendish Ct Lebanon, NH 03766 |
Contact | Venkat Krishnaswamy |
Correspondent | Farzeen Christie DoseOptics LLC 16 Cavendish Ct Lebanon, NH 03766 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-08-17 |
Decision Date | 2021-09-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860009184503 | K212606 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BEAMSITE 97163877 not registered Live/Pending |
DoseOptics LLC 2021-12-09 |