510(k) K073273
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