Cleared Traditional

F&P SIMPLUS FULL FACE MASK

K130328 · Fisher & Paykel Healthcare Limited · Anesthesiology
Jun 2013
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K130328 is an FDA 510(k) clearance for the F&P SIMPLUS FULL FACE MASK, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Fisher & Paykel Healthcare Limited (Auckland, NZ). The FDA issued a Cleared decision on June 5, 2013, 114 days after receiving the submission on February 11, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K130328 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 2013
Decision Date June 05, 2013
Days to Decision 114 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZD — Ventilator, Non-continuous (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905

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