Cleared Traditional

DISPOSABLE MOUTHPIECE

K791537 · Hospitak, Inc. · Anesthesiology
Sep 1979
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K791537 is an FDA 510(k) clearance for the DISPOSABLE MOUTHPIECE, a Mouthpiece, Breathing (Class I — General Controls, product code BYP), submitted by Hospitak, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 7, 1979, 28 days after receiving the submission on August 10, 1979. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5620.

Submission Details

510(k) Number K791537 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 1979
Decision Date September 07, 1979
Days to Decision 28 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BYP — Mouthpiece, Breathing
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5620

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