Cleared Traditional

THAYER MIP ADAPTER

K904917 · Thayer Medical Corp. · Anesthesiology
Jan 1991
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K904917 is an FDA 510(k) clearance for the THAYER MIP ADAPTER, a Meter, Airway Pressure (inspiratory Force) (Class II — Special Controls, product code BXR), submitted by Thayer Medical Corp. (Tucson, US). The FDA issued a Cleared decision on January 28, 1991, 89 days after receiving the submission on October 31, 1990. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1780.

Submission Details

510(k) Number K904917 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 1990
Decision Date January 28, 1991
Days to Decision 89 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BXR — Meter, Airway Pressure (inspiratory Force)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1780

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