FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WAVE FLUORESCENT MAGNIFIER
K Number: K936088
·
Decision Apr 26, 1994
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
36
Applicant Total
15
Review Days
126
Basic Information
- Device Name
- WAVE FLUORESCENT MAGNIFIER
- K Number
- K936088
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6320
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- BURTON MEDICAL PRODUCTS CORP.
- Date Received
- December 21, 1993
- Decision Date
- April 26, 1994
- Product Code
- KZF
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KZF | Device, Medical Examination, Ac Powered | FDA class 1 | General Hospital |
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|---|---|---|---|
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| K901706 | LIGHT, HEAD, EXAMINATION | Jul 19, 1990 | Substantially Equivalent |
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