Cleared Traditional

SOF-TOUCH NASAL CANNULA CAT.#304 & 305

K802062 · Hospitak, Inc. · Anesthesiology
Sep 1980
Decision
13d
Days
Class 1
Risk

About This 510(k) Submission

K802062 is an FDA 510(k) clearance for the SOF-TOUCH NASAL CANNULA CAT.#304 & 305, a Cannula, Nasal, Oxygen (Class I — General Controls, product code CAT), submitted by Hospitak, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1980, 13 days after receiving the submission on August 27, 1980. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5340.

Submission Details

510(k) Number K802062 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 1980
Decision Date September 09, 1980
Days to Decision 13 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CAT — Cannula, Nasal, Oxygen
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5340

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