Cleared Traditional

50 W METAL HALIDE ILLUMINATOR, VES 0501.

K992447 · Angiolaz, Inc. · Gastroenterology & Urology
Oct 1999
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K992447 is an FDA 510(k) clearance for the 50 W METAL HALIDE ILLUMINATOR, VES 0501., a Light Source, Fiberoptic, Routine (Class II — Special Controls, product code FCW), submitted by Angiolaz, Inc. (Bellows Falls, US). The FDA issued a Cleared decision on October 20, 1999, 90 days after receiving the submission on July 22, 1999. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K992447 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 1999
Decision Date October 20, 1999
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code FCW — Light Source, Fiberoptic, Routine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500

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