Cleared Traditional

DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING

K951345 · Catheter Research, Inc. · Anesthesiology

Apr 1995

Decision

22d

Days

Class 1

Risk

About This 510(k) Submission

K951345 is an FDA 510(k) clearance for the DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING, a Connector, Airway (extension) (Class I — General Controls, product code BZA), submitted by Catheter Research, Inc. (Indianapolis, US). The FDA issued a Cleared decision on April 14, 1995, 22 days after receiving the submission on March 23, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5810.

Submission Details

510(k) Number	K951345 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 23, 1995
Decision Date	April 14, 1995
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement