FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DOWNING SPECTRAL ILLUMINATOR
K Number: K833446
·
Decision Mar 12, 1984
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
17
Applicant Total
3
Review Days
159
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Basic Information
- Device Name
- DOWNING SPECTRAL ILLUMINATOR
- K Number
- K833446
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1630
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Vision Health Technology
- Date Received
- October 5, 1983
- Decision Date
- March 12, 1984
- Product Code
- HLX
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HLX | Photostimulator, Ac-Powered | FDA class 2 | Ophthalmic |
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