Quantum Mini Ventilation Module
K-Number: K210669 · 2021-05-04
ApplicantSpectrum Medical , Ltd.
Decision Date2021-05-04
Product CodeDTX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Quantum Mini Ventilation Module is a medical device manufactured by Spectrum Medical , Ltd.. It received FDA 510(k) clearance on 2021-05-04 under approval number K210669. 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 Mini Ventilation Module?
Quantum Mini Ventilation Module is a medical device that received FDA 510(k) clearance on 2021-05-04. It is manufactured by Spectrum Medical , Ltd.. The 510(k) number is K210669.
When was Quantum Mini Ventilation Module approved by the FDA?
Quantum Mini Ventilation Module received FDA 510(k) clearance on 2021-05-04, under approval number K210669.
What company makes Quantum Mini Ventilation Module?
Quantum Mini Ventilation Module is manufactured by Spectrum Medical , Ltd..
What is the FDA product code for Quantum Mini Ventilation Module?
The FDA product code for Quantum Mini 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.