CONTACT LENS OPHTHALMODYNAMOMETER
FDA 510(k) clearance K052674 · decided 2006-05-24
Clearance details
- K-number
- K052674
- Device name
- CONTACT LENS OPHTHALMODYNAMOMETER
- Applicant
- Meditron, GmbH
- Decision
- Substantially Equivalent
- Date received
- 2005-09-27
- Decision date
- 2006-05-24
- Days to decision
- 239 days
- Clearance type
- Traditional
- Product code
- NYK
- Device class
- 2
- Regulation number
- 886.1385
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Golden, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.