Cleared Traditional

DISPOSABLE ANESTHESIA MASK

K841240 · Hospitak, Inc. · Anesthesiology
Apr 1984
Decision
13d
Days
Class 1
Risk

About This 510(k) Submission

K841240 is an FDA 510(k) clearance for the DISPOSABLE ANESTHESIA MASK, a Mask, Gas, Anesthetic (Class I — General Controls, product code BSJ), submitted by Hospitak, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1984, 13 days after receiving the submission on March 23, 1984. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5550.

Submission Details

510(k) Number K841240 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 1984
Decision Date April 05, 1984
Days to Decision 13 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BSJ — Mask, Gas, Anesthetic
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5550

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