CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000
FDA 510(k) clearance K083291 · decided 2009-05-05
Clearance details
- K-number
- K083291
- Device name
- CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000
- Applicant
- Carl Zeiss Meditec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-11-07
- Decision date
- 2009-05-05
- Days to decision
- 179 days
- Clearance type
- Traditional
- Product code
- OBO
- Device class
- 2
- Regulation number
- 886.1570
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Dublin, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cirrus HD-OCT Model 400 instruments; new and refurbished, with or upgraded to, version 4.6 recall (Z-2126-2011) | Carl Zeiss Meditec Inc | 2011-05-02 |
| Cirrus HD-OCT Model 4000 instruments, new and refurbished, distributed with, or upgraded t recall (Z-2127-2011) | Carl Zeiss Meditec Inc | 2011-05-02 |
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