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FDA PMA

Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents

PMA Number: P210018 · 2022-03-17

ApplicantDatex-Ohmeda, Inc., A General Electric Company
Decision Date2022-03-17
PMA NumberP210018
Product CodeQSF
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeAN

Device Summary

Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents is a medical device manufactured by Datex-Ohmeda, Inc., A General Electric Company. It received FDA Premarket Approval (PMA) on 2022-03-17 under PMA number P210018. The device is classified under FDA product code QSF. It was reviewed by the AN advisory panel. This device is classified as Class III by the FDA. Class III devices subject to the most stringent regulatory controls. These devices generally require premarket approval (PMA) because they support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of U. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to submit clinical trial data demonstrating the safety and effectiveness of the device. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents?

Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents is a medical device that received FDA Premarket Approval (PMA) on 2022-03-17. It is manufactured by Datex-Ohmeda, Inc., A General Electric Company. The PMA number is P210018.

When did Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents receive FDA PMA approval?

Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents received FDA PMA approval on 2022-03-17, under approval number P210018.

What company makes Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents?

Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents is manufactured by Datex-Ohmeda, Inc., A General Electric Company.

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to provide clinical data proving safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents?

The FDA product code for Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents is QSF.

What FDA device class is Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents?

Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents is classified as Class III by the FDA.

Related Clinical Trials

NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT05701917 DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis RECRUITING NCT06682013 Virtual Agent Feasibility in Oncology Patients (NTT Data) WITHDRAWN NCT07517484 Light and Anesthesia RECRUITING NCT07611903 HFNC Versus Microstream Advance Nasal Cannula for Oxygenation During ERCP NOT_YET_RECRUITING NCT07370051 Effect of Topical Oxygen and LED Light Therapy on Nipple Crack NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40947420 Software as Medical Devices: requirements and regulatory landscape in the United States. Expert review of medical devices (2025) PMID: 39961588 The use of predetermined change control plans to enable the release of new versions of software as a medical device. Expert review of medical devices (2025) PMID: 39915308 CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software. NPJ digital medicine (2025)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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