CDR Panx, Model 4792
FDA 510(k) K031291 · Schick Technologies, Inc.
510(k) numberK031291
Submission
- Device name
- CDR Panx, Model 4792
- Applicant
- Schick Technologies, Inc.
Long Island City, NY, US - Received
- April 23, 2003
- Decision date
- May 5, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was CDR Panx, Model 4792 cleared by the FDA?
CDR Panx, Model 4792 (K031291) received a 510(k) decision of Substantially Equivalent on May 5, 2003, 12 days after the submission was received.
What is the product code of K031291?
The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.