Cleared Traditional

RHINOTHERM ULTRA 2

K894734 · Twinmed Products, Inc. · Anesthesiology

Feb 1990

Decision

207d

Days

Class 1

Risk

About This 510(k) Submission

K894734 is an FDA 510(k) clearance for the RHINOTHERM ULTRA 2, a Humidifier, Non-direct Patient Interface (home-use) (Class I — General Controls, product code KFZ), submitted by Twinmed Products, Inc. (Santa Monica, US). The FDA issued a Cleared decision on February 16, 1990, 207 days after receiving the submission on July 24, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5460.

Submission Details

510(k) Number	K894734 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 24, 1989
Decision Date	February 16, 1990
Days to Decision	207 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—