510(k) K923455
K923455 is an FDA 510(k) premarket notification submitted by Varian Canada, Inc. for the device "HFG 350, 650, 1050". The FDA issued a decision of Substantially Equivalent on December 28, 1992. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Varian Canada, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 28, 1992
- Date Received
- July 14, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type