Cleared Traditional

CARNATION TRACHEOSTOMY MASKS

K894457 · Dadsun Corp., Ltd. · Anesthesiology

Oct 1989

Decision

87d

Days

Class 1

Risk

About This 510(k) Submission

K894457 is an FDA 510(k) clearance for the CARNATION TRACHEOSTOMY MASKS, a Mask, Oxygen, Low Concentration, Venturi (Class I — General Controls, product code BYF), submitted by Dadsun Corp., Ltd. (Taipei, TW). The FDA issued a Cleared decision on October 13, 1989, 87 days after receiving the submission on July 18, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5600.

Submission Details

510(k) Number	K894457 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 18, 1989
Decision Date	October 13, 1989
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—