Cirrus Hd-Oct, Model 4000
FDA 510(k) K063378 · Carl Zeiss Meditec, Inc.
510(k) numberK063378
Submission
- Device name
- Cirrus Hd-Oct, Model 4000
- Applicant
- Carl Zeiss Meditec, Inc.
Dublin, CA, US - Received
- November 8, 2006
- Decision date
- January 26, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Cirrus Hd-Oct, Model 4000 cleared by the FDA?
Cirrus Hd-Oct, Model 4000 (K063378) received a 510(k) decision of Substantially Equivalent on January 26, 2007, 79 days after the submission was received.
What is the product code of K063378?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.