ANISEIKONIA INSPECTOR
FDA 510(k) clearance K013110 · decided 2001-12-19
Clearance details
- K-number
- K013110
- Device name
- ANISEIKONIA INSPECTOR
- Applicant
- Optical Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-11
- Decision date
- 2001-12-19
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- HJT
- Device class
- 1
- Regulation number
- 886.1340
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Issaquah, WA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AA-1 SYSTEM (K012530) | Neurovision, Inc. | 2001-08-31 |
Recalls involving this device
No recalls on record reference this clearance.