Cleared Traditional

Megadyne Foot Switch

K191328 · Megadyne Medical Products, Inc. · General Hospital
Jul 2019
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K191328 is an FDA 510(k) clearance for the Megadyne Foot Switch, a Apparatus, Exhaust, Surgical (Class II — Special Controls, product code FYD), submitted by Megadyne Medical Products, Inc. (Draper, US). The FDA issued a Cleared decision on July 26, 2019, 71 days after receiving the submission on May 16, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.5070.

Submission Details

510(k) Number K191328 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2019
Decision Date July 26, 2019
Days to Decision 71 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FYD — Apparatus, Exhaust, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5070

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