Multicam I 8X10
FDA 510(k) K912341 · Camtronics, Ltd.
510(k) numberK912341
Submission
- Device name
- Multicam I 8X10
- Applicant
- Camtronics, Ltd.
Hartland, WI, US - Received
- May 24, 1991
- Decision date
- August 26, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Multicam I 8X10 cleared by the FDA?
Multicam I 8X10 (K912341) received a 510(k) decision of Substantially Equivalent on August 26, 1991, 94 days after the submission was received.
What is the product code of K912341?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.