Belmax CM Model X168
FDA 510(k) K062529 · Takara Belmont USA, Inc.
510(k) numberK062529
Submission
- Device name
- Belmax CM Model X168
- Applicant
- Takara Belmont USA, Inc.
West Cadwell, NJ, US - Received
- August 29, 2006
- Decision date
- October 5, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Belmax CM Model X168 cleared by the FDA?
Belmax CM Model X168 (K062529) received a 510(k) decision of Substantially Equivalent on October 5, 2006, 37 days after the submission was received.
What is the product code of K062529?
The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.