Cleared Traditional

NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202

K102120 · Hsiner Co., Ltd. · Anesthesiology
Aug 2011
Decision
379d
Days
Class 2
Risk

About This 510(k) Submission

K102120 is an FDA 510(k) clearance for the NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Hsiner Co., Ltd. (Temecula, US). The FDA issued a Cleared decision on August 12, 2011, 379 days after receiving the submission on July 29, 2010. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K102120 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2010
Decision Date August 12, 2011
Days to Decision 379 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBK — Ventilator, Continuous, Facility Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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