510(k) K073273

EQUAL DOSE 1.0 by Nucletron Corporation — Product Code IYE

K073273 is an FDA 510(k) premarket notification submitted by Nucletron Corporation for the device "EQUAL DOSE 1.0". The FDA issued a decision of Substantially Equivalent on December 11, 2007. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Nucletron Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2007
Date Received
November 21, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type