Cleared Traditional

STABILTRACH

K935171 · B&B Medical Technologies, Inc. · Anesthesiology
Dec 1993
Decision
37d
Days
Class 1
Risk

About This 510(k) Submission

K935171 is an FDA 510(k) clearance for the STABILTRACH, a Device, Fixation, Tracheal Tube (Class I — General Controls, product code CBH), submitted by B&B Medical Technologies, Inc. (Orangevale, US). The FDA issued a Cleared decision on December 2, 1993, 37 days after receiving the submission on October 26, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5770.

Submission Details

510(k) Number K935171 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 1993
Decision Date December 02, 1993
Days to Decision 37 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code CBH — Device, Fixation, Tracheal Tube
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5770

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