Cleared Traditional

INSPIRATORY FORCE PRESSURE ADAPTOR

K812067 · Airlife, Inc. · Anesthesiology
Aug 1981
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K812067 is an FDA 510(k) clearance for the INSPIRATORY FORCE PRESSURE ADAPTOR, a Connector, Airway (extension) (Class I — General Controls, product code BZA), submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1981, 22 days after receiving the submission on July 21, 1981. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5810.

Submission Details

510(k) Number K812067 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 1981
Decision Date August 12, 1981
Days to Decision 22 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BZA — Connector, Airway (extension)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5810

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