Cleared Traditional

ACCUTRON POLLUTION REDUCER

K790638 · Parker Laboratories, Inc. · Anesthesiology
May 1979
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K790638 is an FDA 510(k) clearance for the ACCUTRON POLLUTION REDUCER, a Mask, Gas, Anesthetic (Class I — General Controls, product code BSJ), submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 25, 1979, 56 days after receiving the submission on March 30, 1979. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5550.

Submission Details

510(k) Number K790638 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 1979
Decision Date May 25, 1979
Days to Decision 56 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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