Cleared Traditional

CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100

K992606 · Canon USA, Inc. · Ophthalmic
Jun 2000
Decision
323d
Days
Class 2
Risk

About This 510(k) Submission

K992606 is an FDA 510(k) clearance for the CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100, a Ophthalmoscope, Ac-powered (Class II — Special Controls, product code HLI), submitted by Canon USA, Inc. (Lake Success, US). The FDA issued a Cleared decision on June 21, 2000, 323 days after receiving the submission on August 3, 1999. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K992606 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 1999
Decision Date June 21, 2000
Days to Decision 323 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
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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