Cleared Traditional

ALGO 7i

K211147 · Path Medical GmbH · Ear, Nose, Throat
Oct 2021
Decision
178d
Days
Class 2
Risk

About This 510(k) Submission

K211147 is an FDA 510(k) clearance for the ALGO 7i, a Stimulator, Auditory, Evoked Response (Class II — Special Controls, product code GWJ), submitted by Path Medical GmbH (Germering, DE). The FDA issued a Cleared decision on October 14, 2021, 178 days after receiving the submission on April 19, 2021. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number K211147 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2021
Decision Date October 14, 2021
Days to Decision 178 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code GWJ — Stimulator, Auditory, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1900

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