STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE— 510(k) K033123
Substantially EquivalentCarl Zeiss Meditec, Inc.
FDA 510(k) clearance K033123 for STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE, Substantially Equivalent on 2004-04-20. Applicant: Carl Zeiss Meditec, Inc.. Device class: 2.
Clearance details
- Applicant
- Carl Zeiss Meditec, Inc.
- Product code
- Code HLI
- Device class
- Class 2
- Regulation
- 21 CFR 886.1570
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Dublin, CA, US
Recent devices under product code HLI
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