Cleared Traditional

HME-BOOSTER

K990614 · King Systems Corp. · Anesthesiology
May 2000
Decision
453d
Days
Class 2
Risk

About This 510(k) Submission

K990614 is an FDA 510(k) clearance for the HME-BOOSTER, a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by King Systems Corp. (Noblesville, US). The FDA issued a Cleared decision on May 23, 2000, 453 days after receiving the submission on February 25, 1999. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.

Submission Details

510(k) Number K990614 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 1999
Decision Date May 23, 2000
Days to Decision 453 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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