Cleared Traditional

CUFFCHECK

K881178 · Dhd Medical Products Div. Diemolding Corp. · Anesthesiology
Apr 1988
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K881178 is an FDA 510(k) clearance for the CUFFCHECK, a Cuff, Tracheal Tube, Inflatable (Class II — Special Controls, product code BSK), submitted by Dhd Medical Products Div. Diemolding Corp. (Canastota, US). The FDA issued a Cleared decision on April 14, 1988, 27 days after receiving the submission on March 18, 1988. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5750.

Submission Details

510(k) Number K881178 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 1988
Decision Date April 14, 1988
Days to Decision 27 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