Cleared Traditional

THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR

K941026 · Thayer Medical Corp. · Anesthesiology
Aug 1994
Decision
167d
Days
Class 1
Risk

About This 510(k) Submission

K941026 is an FDA 510(k) clearance for the THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR, a Connector, Airway (extension) (Class I — General Controls, product code BZA), submitted by Thayer Medical Corp. (Tucson, US). The FDA issued a Cleared decision on August 18, 1994, 167 days after receiving the submission on March 4, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5810.

Submission Details

510(k) Number K941026 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 1994
Decision Date August 18, 1994
Days to Decision 167 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

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

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