PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS
FDA 510(k) clearance K053425 · decided 2006-01-09
Clearance details
- K-number
- K053425
- Device name
- PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS
- Applicant
- Precision Optics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-12-08
- Decision date
- 2006-01-09
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- HLJ
- Device class
- 2
- Regulation number
- 886.1570
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Gardner, MA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.