Cleared Traditional

CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR

K902114 · Diemolding Corp. · Anesthesiology
Jul 1990
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K902114 is an FDA 510(k) clearance for the CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR, a Cuff, Tracheal Tube, Inflatable (Class II — Special Controls, product code BSK), submitted by Diemolding Corp. (Canastota, US). The FDA issued a Cleared decision on July 18, 1990, 68 days after receiving the submission on May 11, 1990. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5750.

Submission Details

510(k) Number K902114 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 1990
Decision Date July 18, 1990
Days to Decision 68 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BSK — Cuff, Tracheal Tube, Inflatable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5750