Cleared Traditional

ERG-JET ELECTRODE

K830557 · Universo S.A. · Gastroenterology & Urology

Mar 1983

Decision

36d

Days

Class 2

Risk

About This 510(k) Submission

K830557 is an FDA 510(k) clearance for the ERG-JET ELECTRODE, a Electrode, Corneal (Class II — Special Controls, product code HLZ), submitted by Universo S.A. (Walker, US). The FDA issued a Cleared decision on March 31, 1983, 36 days after receiving the submission on February 23, 1983. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 886.1220.

Submission Details

510(k) Number	K830557 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 23, 1983
Decision Date	March 31, 1983
Days to Decision	36 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—