Cleared Traditional

THERASTEAM PERSONAL STEAM INHALER

K950116 · Kaz, Inc. · Anesthesiology

Feb 1995

Decision

30d

Days

Class 1

Risk

About This 510(k) Submission

K950116 is an FDA 510(k) clearance for the THERASTEAM PERSONAL STEAM INHALER, a Humidifier, Non-direct Patient Interface (home-use) (Class I — General Controls, product code KFZ), submitted by Kaz, Inc. (Washington, US). The FDA issued a Cleared decision on February 10, 1995, 30 days after receiving the submission on January 11, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5460.

Submission Details

510(k) Number	K950116 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 11, 1995
Decision Date	February 10, 1995
Days to Decision	30 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF