Cleared Traditional

DISPOSABLE FLEX TUBE

K954197 · Engstrom Medical · Anesthesiology

Oct 1995

Decision

50d

Days

Class 1

Risk

About This 510(k) Submission

K954197 is an FDA 510(k) clearance for the DISPOSABLE FLEX TUBE, a Connector, Airway (extension) (Class I — General Controls, product code BZA), submitted by Engstrom Medical (S-161 02 Bromma, SE). The FDA issued a Cleared decision on October 26, 1995, 50 days after receiving the submission on September 6, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5810.

Submission Details

510(k) Number	K954197 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 06, 1995
Decision Date	October 26, 1995
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF