LogoFDA 510(k) Search
K Number
K001609
Device Name
MALLARD AIR OXYGEN ACCUBLENDER
Manufacturer
MALLARD MEDICAL, INC.
Date Cleared
2000-08-10

(78 days)

Product Code
BZR
Regulation Number
868.5330
Type
Traditional
Panel
Anesthesiology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 868.5330 Breathing gas mixer.

(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).