Cleared Traditional

PMH 1000 HEATED HUMIDIFIER

K013856 · Pegasus Research Corp. · Anesthesiology
Feb 2003
Decision
472d
Days
Class 2
Risk

About This 510(k) Submission

K013856 is an FDA 510(k) clearance for the PMH 1000 HEATED HUMIDIFIER, a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by Pegasus Research Corp. (Santa Ana, US). The FDA issued a Cleared decision on February 21, 2003, 472 days after receiving the submission on November 6, 2001. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.

Submission Details

510(k) Number K013856 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2001
Decision Date February 21, 2003
Days to Decision 472 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BTT — Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5450

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