Cleared Abbreviated

DemeMASK

K201479 · Demetech Corporation · General Hospital
Jul 2020
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K201479 is an FDA 510(k) clearance for the DemeMASK, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Demetech Corporation (Miami Lakes, US). The FDA issued a Cleared decision on July 24, 2020, 50 days after receiving the submission on June 4, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K201479 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2020
Decision Date July 24, 2020
Days to Decision 50 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FXX — Mask, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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