FULL AUTO TONOMETER MODEL TX-20
FDA 510(k) clearance K111710 · decided 2011-09-20
Clearance details
- K-number
- K111710
- Device name
- FULL AUTO TONOMETER MODEL TX-20
- Applicant
- Canon Inc. -Medical Equipment Group
- Decision
- Substantially Equivalent
- Date received
- 2011-06-20
- Decision date
- 2011-09-20
- Days to decision
- 92 days
- Clearance type
- Special
- Product code
- HKX
- Device class
- 2
- Regulation number
- 886.1930
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Tachikawa-Shi, Tokyo, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.