| Device Classification Name |
tomography, optical coherence |
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|---|---|---|---|---|
| 510(k) Number | K111157 | |||
| Device Name | CIRRUS RD-OCT WITH RETINAL NERVE FIBER LAYER, OPTIC DISC, MACULAR, GANGLION CELL AND ASIAN NORMATIVE DATABASES | |||
| Applicant |
|
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| Applicant Contact | judith a brimacombe | |||
| Correspondent |
|
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| Correspodent Contact | judith a brimacombe | |||
| Regulation Number | 886.1570 | |||
| Classification Product Code |
|
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| Date Received | 04/25/2011 | |||
| Decision Date | 01/19/2012 | |||
| Decision |
substantially equivalent (SESE) |
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| Regulation Medical Specialty |
Ophthalmic |
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| 510k Review Panel |
Neurology |
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| summary |
summary |
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| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |