Digital Disk Recorder W/Dualpath ARCHIVE/30-60 Opt
FDA 510(k) K924164 · Eigen
510(k) numberK924164
Submission
- Device name
- Digital Disk Recorder W/Dualpath ARCHIVE/30-60 Opt
- Applicant
- Eigen
Nevada City, CA, US - Received
- August 19, 1992
- Decision date
- November 23, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Digital Disk Recorder W/Dualpath ARCHIVE/30-60 Opt cleared by the FDA?
Digital Disk Recorder W/Dualpath ARCHIVE/30-60 Opt (K924164) received a 510(k) decision of Substantially Equivalent on November 23, 1992, 96 days after the submission was received.
What is the product code of K924164?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.