Cleared Traditional

GALEMED CPAP MASK

K072755 · Galemed Corp. · Anesthesiology
Nov 2007
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K072755 is an FDA 510(k) clearance for the GALEMED CPAP MASK, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Galemed Corp. (Bonita Springs, US). The FDA issued a Cleared decision on November 16, 2007, 50 days after receiving the submission on September 27, 2007. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K072755 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2007
Decision Date November 16, 2007
Days to Decision 50 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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