FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HI-LO FLOOR STANDING EXAM. LIGHT
K Number: K842135
·
Decision Jul 6, 1984
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
36
Applicant Total
3
Review Days
37
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Basic Information
- Device Name
- HI-LO FLOOR STANDING EXAM. LIGHT
- K Number
- K842135
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6320
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Good-Lite Co.
- Date Received
- May 30, 1984
- Decision Date
- July 6, 1984
- 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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