Quantum Ventilation Module
K-Number: K202733 · 2020-10-16
ApplicantSpectrum Medical , Ltd.
Decision Date2020-10-16
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 2020-10-16 under approval number K202733. 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 2020-10-16. It is manufactured by Spectrum Medical , Ltd.. The 510(k) number is K202733.
When was Quantum Ventilation Module approved by the FDA?
Quantum Ventilation Module received FDA 510(k) clearance on 2020-10-16, under approval number K202733.
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.