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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceEt Control
Generic NameSoftware option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents
ApplicantDatex-Ohmeda, Inc., a General Electric Company
P.O. Box 7550
Madison, WI 53707-7550
PMA NumberP210018
Date Received05/03/2021
Decision Date03/17/2022
Product Code QSF 
Docket Number 22M-0360
Notice Date 03/21/2022
Advisory Committee Anesthesiology
Clinical TrialsNCT02972892
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for Et Control indicated for use with the Datex-Ohmeda Aisys CS2 anesthesia system to support clinicians in maintaining the targeted end tidal oxygen and end tidal anesthetic agent concentrations that the clinician sets during an anesthetic procedure, by making multiple, limited adjustments to the fresh gas composition and total flow. The Et Control feature is indicated for patients, 18 years of age and older.The Aisys CS2 anesthesia system and the Et Control feature are intended for prescription use only.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  
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