HFG 350, 650, 1050
FDA 510(k) K923455 · Varian Canada, Inc.
510(k) numberK923455
Submission
- Device name
- HFG 350, 650, 1050
- Applicant
- Varian Canada, Inc.
Canada L7g 2j4, CA - Received
- July 14, 1992
- Decision date
- December 28, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was HFG 350, 650, 1050 cleared by the FDA?
HFG 350, 650, 1050 (K923455) received a 510(k) decision of Substantially Equivalent on December 28, 1992, 167 days after the submission was received.
What is the product code of K923455?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.