Cleared Traditional

ivi N3003 Surgical face Mask, ivi N6006 Surgical mask

K201896 · Iob Medical, Inc. · General Hospital
Mar 2021
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K201896 is an FDA 510(k) clearance for the ivi N3003 Surgical face Mask, ivi N6006 Surgical mask, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Iob Medical, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on March 30, 2021, 265 days after receiving the submission on July 8, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K201896 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2020
Decision Date March 30, 2021
Days to Decision 265 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

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

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