Cleared Traditional

HELIO2 BLENDER

K090781 · Precision Medical, Inc. · Anesthesiology
Aug 2009
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K090781 is an FDA 510(k) clearance for the HELIO2 BLENDER, a Mixer, Breathing Gases, Anesthesia Inhalation (Class II — Special Controls, product code BZR), submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on August 13, 2009, 143 days after receiving the submission on March 23, 2009. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5330.

Submission Details

510(k) Number K090781 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2009
Decision Date August 13, 2009
Days to Decision 143 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZR — Mixer, Breathing Gases, Anesthesia Inhalation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5330

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