Cleared Traditional

F&P Eson 2 Nasal Mask

K153505 · Fisher & Paykel Healthcare Limited · Anesthesiology
Sep 2016
Decision
288d
Days
Class 2
Risk

About This 510(k) Submission

K153505 is an FDA 510(k) clearance for the F&P Eson 2 Nasal 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 September 20, 2016, 288 days after receiving the submission on December 7, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K153505 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 2015
Decision Date September 20, 2016
Days to Decision 288 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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