Cleared Traditional

VIROTHERM HUMIDIFIER

K915603 · Virotherm Laboratory · Anesthesiology

Oct 1992

Decision

311d

Days

Class 1

Risk

About This 510(k) Submission

K915603 is an FDA 510(k) clearance for the VIROTHERM HUMIDIFIER, a Humidifier, Non-direct Patient Interface (home-use) (Class I — General Controls, product code KFZ), submitted by Virotherm Laboratory (Saratoga, US). The FDA issued a Cleared decision on October 22, 1992, 311 days after receiving the submission on December 16, 1991. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5460.

Submission Details

510(k) Number	K915603 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 16, 1991
Decision Date	October 22, 1992
Days to Decision	311 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement