Cleared Traditional

BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR

K884638 · Instrumentation Industries, Inc. · Anesthesiology

Nov 1988

Decision

16d

Days

Class 2

Risk

About This 510(k) Submission

K884638 is an FDA 510(k) clearance for the BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR, a Cuff, Tracheal Tube, Inflatable (Class II — Special Controls, product code BSK), submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on November 23, 1988, 16 days after receiving the submission on November 7, 1988. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5750.

Submission Details

510(k) Number	K884638 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 07, 1988
Decision Date	November 23, 1988
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—