PSC-1 W/Other Numerical
FDA 510(k) K903821 · Eigen
510(k) numberK903821
Submission
- Device name
- PSC-1 W/Other Numerical
- Applicant
- Eigen
Nevada City, CA, US - Received
- August 20, 1990
- Decision date
- November 7, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was PSC-1 W/Other Numerical cleared by the FDA?
PSC-1 W/Other Numerical (K903821) received a 510(k) decision of Substantially Equivalent on November 7, 1990, 79 days after the submission was received.
What is the product code of K903821?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.