Quantum Ventilation Module
K-Number: K181942 · 2018-10-18
ApplicantSpectrum Medical , Ltd.
Decision Date2018-10-18
Product CodeDTX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Quantum Ventilation Module is a medical device manufactured by Spectrum Medical , Ltd.. It received FDA 510(k) clearance on 2018-10-18 under approval number K181942. The device is classified under product code DTX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Quantum Ventilation Module?
Quantum Ventilation Module is a medical device that received FDA 510(k) clearance on 2018-10-18. It is manufactured by Spectrum Medical , Ltd.. The 510(k) number is K181942.
When was Quantum Ventilation Module approved by the FDA?
Quantum Ventilation Module received FDA 510(k) clearance on 2018-10-18, under approval number K181942.
What company makes Quantum Ventilation Module?
Quantum Ventilation Module is manufactured by Spectrum Medical , Ltd..
What is the FDA product code for Quantum Ventilation Module?
The FDA product code for Quantum Ventilation Module is DTX.
Other Devices by Spectrum Medical , Ltd.
Related Devices (Code: DTX)
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.