Cleared Traditional

NARKOMED ULTRASONIC FLOW SENSOR

K974193 · Draeger Medical, Inc. · Anesthesiology
Jan 1998
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K974193 is an FDA 510(k) clearance for the NARKOMED ULTRASONIC FLOW SENSOR, a Gas-machine, Anesthesia (Class II — Special Controls, product code BSZ), submitted by Draeger Medical, Inc. (Telford, US). The FDA issued a Cleared decision on January 28, 1998, 82 days after receiving the submission on November 7, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K974193 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 1997
Decision Date January 28, 1998
Days to Decision 82 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSZ — Gas-machine, Anesthesia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5160

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