Stratusoct with RNFL & Macula Normative Database
FDA 510(k) K033123 · Carl Zeiss Meditec, Inc.
510(k) numberK033123
Submission
- Device name
- Stratusoct with RNFL & Macula Normative Database
- Applicant
- Carl Zeiss Meditec, Inc.
Dublin, CA, US - Received
- September 30, 2003
- Decision date
- April 20, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HLI – Ophthalmoscope, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1570
- Specialty
- Ophthalmic
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Questions and answers
When was Stratusoct with RNFL & Macula Normative Database cleared by the FDA?
Stratusoct with RNFL & Macula Normative Database (K033123) received a 510(k) decision of Substantially Equivalent on April 20, 2004, 203 days after the submission was received.
What is the product code of K033123?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.