Panoura Ultra Pan and Panoura Ultra Pan/Ceph Panoramic/Cephalometric X-Ray Unit
FDA 510(k) K965072 · Kaycor Intl., Ltd.
510(k) numberK965072
Submission
- Device name
- Panoura Ultra Pan and Panoura Ultra Pan/Ceph Panoramic/Cephalometric X-Ray Unit
- Applicant
- Kaycor Intl., Ltd.
Northbrook, IL, US - Received
- December 19, 1996
- Decision date
- January 27, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Panoura Ultra Pan and Panoura Ultra Pan/Ceph Panoramic/Cephalometric X-Ray Unit cleared by the FDA?
Panoura Ultra Pan and Panoura Ultra Pan/Ceph Panoramic/Cephalometric X-Ray Unit (K965072) received a 510(k) decision of Substantially Equivalent on January 27, 1997, 39 days after the submission was received.
What is the product code of K965072?
The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.