Cleared Traditional

K871189 - SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380
(FDA 510(k) Clearance)

K871189 · Sunbeam Appliance Service Co. · Anesthesiology

May 1987

Decision

45d

Days

Class 1

Risk

K871189 is an FDA 510(k) clearance for the SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380, a Humidifier, Non-direct Patient Interface (home-use) (Class I — General Controls, product code KFZ), submitted by Sunbeam Appliance Service Co. (Downers Grove, US). The FDA issued a Cleared decision on May 8, 1987, 45 days after receiving the submission on March 24, 1987. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5460.

Submission Details

510(k) Number	K871189 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 24, 1987
Decision Date	May 08, 1987
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—