510(k) K913119
K913119 is an FDA 510(k) premarket notification submitted by Varian Assoc., Inc. for the device "VARIAN C-SERIES CLINACS (CLINAC 2300C/D)". The FDA issued a decision of Substantially Equivalent on November 7, 1991. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Varian Assoc., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 1991
- Date Received
- July 15, 1991
- 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