CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000— 510(k) K083291
Substantially EquivalentCarl Zeiss Meditec, Inc.
FDA 510(k) clearance K083291 for CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000, Substantially Equivalent on 2009-05-05. Applicant: Carl Zeiss Meditec, Inc.. Device class: 2.
Clearance details
- Applicant
- Carl Zeiss Meditec, Inc.
- Product code
- Code OBO
- Device class
- Class 2
- Regulation
- 21 CFR 886.1570
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dublin, CA, US
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