Cleared Traditional

HUMPHREY OCT SCANNER

K961171 · Carl Zeiss, Inc. · Radiology
Jun 1996
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K961171 is an FDA 510(k) clearance for the HUMPHREY OCT SCANNER, a Ophthalmoscope, Ac-powered (Class II — Special Controls, product code HLI), submitted by Carl Zeiss, Inc. (Thornwood, US). The FDA issued a Cleared decision on June 21, 1996, 88 days after receiving the submission on March 25, 1996. This device falls under the Radiology review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K961171 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 1996
Decision Date June 21, 1996
Days to Decision 88 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code HLI — Ophthalmoscope, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1570

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