Cleared Traditional

TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER

K862919 · Transpirator Technologics, Inc. · Anesthesiology

Nov 1986

Decision

98d

Days

Class 1

Risk

About This 510(k) Submission

K862919 is an FDA 510(k) clearance for the TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER, a Humidifier, Non-direct Patient Interface (home-use) (Class I — General Controls, product code KFZ), submitted by Transpirator Technologics, Inc. (Somerset, US). The FDA issued a Cleared decision on November 7, 1986, 98 days after receiving the submission on August 1, 1986. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5460.

Submission Details

510(k) Number	K862919 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 01, 1986
Decision Date	November 07, 1986
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—