Wave Fluorescent Magnifier
FDA 510(k) K936088 · Burton Medical Products Corp.
510(k) numberK936088
Submission
- Device name
- Wave Fluorescent Magnifier
- Applicant
- Burton Medical Products Corp.
Van Nuys, CA, US - Received
- December 21, 1993
- Decision date
- April 26, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KZF – Device, Medical Examination, Ac Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6320
- Specialty
- General Hospital
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Questions and answers
When was Wave Fluorescent Magnifier cleared by the FDA?
Wave Fluorescent Magnifier (K936088) received a 510(k) decision of Substantially Equivalent on April 26, 1994, 126 days after the submission was received.
What is the product code of K936088?
The FDA product code is KZF – Device, Medical Examination, Ac Powered, a Class I (low risk) device regulated under 21 CFR 880.6320.