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K Number
K002878

Validate with FDA (Live)

Device Name
DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER
Manufacturer
DATEX-OHMEDA, INC.
Date Cleared
2000-09-21

(6 days)

Product Code
CAD
Regulation Number
868.5880
Type
Special
Panel
Anesthesiology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 868.5880 Anesthetic vaporizer.

(a)
Identification. An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.(b)
Classification. Class II (performance standards).