Humphrey Oct Scanner
FDA 510(k) K961171 · Carl Zeiss, Inc.
510(k) numberK961171
Submission
- Device name
- Humphrey Oct Scanner
- Applicant
- Carl Zeiss, Inc.
Thornwood, NY, US - Received
- March 25, 1996
- Decision date
- June 21, 1996
- 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 Humphrey Oct Scanner cleared by the FDA?
Humphrey Oct Scanner (K961171) received a 510(k) decision of Substantially Equivalent on June 21, 1996, 88 days after the submission was received.
What is the product code of K961171?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.