Varian V-3300, Phased Array Ultrason
FDA 510(k) K791775 · Varian Assoc., Inc.
510(k) numberK791775
Submission
- Device name
- Varian V-3300, Phased Array Ultrason
- Applicant
- Varian Assoc., Inc.
Mchenry, IL, US - Received
- September 10, 1979
- Decision date
- October 26, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Varian V-3300, Phased Array Ultrason cleared by the FDA?
Varian V-3300, Phased Array Ultrason (K791775) received a 510(k) decision of Substantially Equivalent on October 26, 1979, 46 days after the submission was received.
What is the product code of K791775?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.