Color Diskstore
FDA 510(k) K922647 · Camtronics, Ltd.
510(k) numberK922647
Submission
- Device name
- Color Diskstore
- Applicant
- Camtronics, Ltd.
Hartland, WI, US - Received
- June 3, 1992
- Decision date
- August 11, 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 Color Diskstore cleared by the FDA?
Color Diskstore (K922647) received a 510(k) decision of Substantially Equivalent on August 11, 1992, 69 days after the submission was received.
What is the product code of K922647?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.