The following data is part of a premarket notification filed by Elekta Ltd. with the FDA for Desktop Pro.
Device ID | K080585 |
510k Number | K080585 |
Device Name: | DESKTOP PRO |
Classification | Accelerator, Linear, Medical |
Applicant | ELEKTA LTD. LINAC HOUSE FLEMING WAY, CRAWLEY West Sussex, GB Rh10 9rr |
Contact | Patrick T.m. Hull |
Correspondent | Patrick T.m. Hull ELEKTA LTD. LINAC HOUSE FLEMING WAY, CRAWLEY West Sussex, GB Rh10 9rr |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-03-03 |
Decision Date | 2008-06-11 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DESKTOP PRO 85948781 4487646 Live/Registered |
Denton Vacuum, L.L.C. 2013-06-03 |