Linus
FDA 510(k) K812398 · Fischer Imaging Corp.
510(k) numberK812398
Submission
- Device name
- Linus
- Applicant
- Fischer Imaging Corp.
Mchenry, IL, US - Received
- August 20, 1981
- Decision date
- November 10, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Linus cleared by the FDA?
Linus (K812398) received a 510(k) decision of Substantially Equivalent on November 10, 1981, 82 days after the submission was received.
What is the product code of K812398?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.