CP 100/30
FDA 510(k) K953292 · Micro-Focus Imaging., Inc.
510(k) numberK953292
Submission
- Device name
- CP 100/30
- Applicant
- Micro-Focus Imaging., Inc.
Wheeling, IL, US - Received
- July 13, 1995
- Decision date
- November 22, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was CP 100/30 cleared by the FDA?
CP 100/30 (K953292) received a 510(k) decision of Substantially Equivalent on November 22, 1995, 132 days after the submission was received.
What is the product code of K953292?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.