Cleared Traditional

TRACH MASK MODEL (245, 246)

K955483 · Hospitak, Inc. · Anesthesiology
Feb 1996
Decision
89d
Days
Class 1
Risk

About This 510(k) Submission

K955483 is an FDA 510(k) clearance for the TRACH MASK MODEL (245, 246), a Mask, Oxygen, Low Concentration, Venturi (Class I — General Controls, product code BYF), submitted by Hospitak, Inc. (Farmingdale, US). The FDA issued a Cleared decision on February 28, 1996, 89 days after receiving the submission on December 1, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5600.

Submission Details

510(k) Number K955483 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 1995
Decision Date February 28, 1996
Days to Decision 89 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BYF — Mask, Oxygen, Low Concentration, Venturi
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5600

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