510(k) K771260
K771260 is an FDA 510(k) premarket notification submitted by Atomic Energy of Canada for the device "LINEAR ACCELERATOR G-2900". The FDA issued a decision of Substantially Equivalent on August 3, 1977. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Atomic Energy of Canada has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 3, 1977
- Date Received
- July 13, 1977
- 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