Cleared Traditional

K802663 - BLOW-BY-SET-UP CONNECTOR-AIRWAY
(FDA 510(k) Clearance)

K802663 · Airlife, Inc. · Anesthesiology
Nov 1980
Decision
15d
Days
Class 1
Risk

K802663 is an FDA 510(k) clearance for the BLOW-BY-SET-UP CONNECTOR-AIRWAY, a Connector, Airway (extension) (Class I — General Controls, product code BZA), submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980, 15 days after receiving the submission on October 28, 1980. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5810.

Submission Details

510(k) Number K802663 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 1980
Decision Date November 12, 1980
Days to Decision 15 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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