FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS
K Number: K053425
·
Decision Jan 9, 2006
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
46
Applicant Total
3
Review Days
32
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Basic Information
- Device Name
- PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS
- K Number
- K053425
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1570
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Precision Optics Corp.
- Date Received
- December 8, 2005
- Decision Date
- January 9, 2006
- Product Code
- HLJ
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HLJ | Ophthalmoscope, Battery-Powered | FDA class 2 | Ophthalmic |
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