STRATUSOCT WITH RNFL NORMATIVE DATABASE
FDA 510(k) clearance K030433 · decided 2003-05-01
Clearance details
- K-number
- K030433
- Device name
- STRATUSOCT WITH RNFL NORMATIVE DATABASE
- Applicant
- Carl Zeiss Meditec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-02-10
- Decision date
- 2003-05-01
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- HLI
- 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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| Record | Firm | Date |
|---|---|---|
| Stratus OCT Model 3000 instruments distributed with version 6.0.0 software, product number recall (Z-2048-2009) | Carl Zeiss Meditec Inc | 2009-09-03 |
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