EYEPORT VISION TRAINING SYSTEM
FDA 510(k) clearance K051684 · decided 2006-03-17
Clearance details
- K-number
- K051684
- Device name
- EYEPORT VISION TRAINING SYSTEM
- Applicant
- Exercise Your Eyes, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-06-23
- Decision date
- 2006-03-17
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- NXR
- Device class
- 1
- Regulation number
- 886.1290
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Kula, HI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.