Orthoslice OS1000 Series; Panoramic Orthoslice Os 1000: OS1000, OS1000E Panoramic and Cephalometric Orthoslice OS1000C,
FDA 510(k) K991455 · Trophy Radiologie
510(k) numberK991455
Submission
- Device name
- Orthoslice OS1000 Series; Panoramic Orthoslice Os 1000: OS1000, OS1000E Panoramic and Cephalometric Orthoslice OS1000C,
- Applicant
- Trophy Radiologie
Marne La Vallee Cedex 2, FR - Received
- April 26, 1999
- Decision date
- June 25, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Orthoslice OS1000 Series; Panoramic Orthoslice Os 1000: OS1000, OS1000E Panoramic and Cephalometric Orthoslice OS1000C, cleared by the FDA?
Orthoslice OS1000 Series; Panoramic Orthoslice Os 1000: OS1000, OS1000E Panoramic and Cephalometric Orthoslice OS1000C, (K991455) received a 510(k) decision of Substantially Equivalent on June 25, 1999, 60 days after the submission was received.
What is the product code of K991455?
The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.