Ultra Compact Video Imager
FDA 510(k) K953165 · International Imaging Electronics
510(k) numberK953165
Submission
- Device name
- Ultra Compact Video Imager
- Applicant
- International Imaging Electronics
Bolingbrook, IL, US - Received
- July 7, 1995
- Decision date
- May 7, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Ultra Compact Video Imager cleared by the FDA?
Ultra Compact Video Imager (K953165) received a 510(k) decision of Substantially Equivalent on May 7, 1996, 305 days after the submission was received.
What is the product code of K953165?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.