510(k) K042794
K042794 is an FDA 510(k) premarket notification submitted by Elekta , Ltd. for the device "BEAM MODULATOR, MODEL 4513 332 8000". The FDA issued a decision of Substantially Equivalent on January 31, 2005. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Elekta , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 2005
- Date Received
- October 7, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accelerator, Linear, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type