K-number	K202733
Device name	Quantum Ventilation Module
Applicant	Spectrum Medical , Ltd.
Product code	DTX
Device class	Class II
Decision date	Oct 16, 2020
Decision	Substantially Equivalent
Regulation	870.4300

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Source

View the full FDA submission: accessdata.fda.gov

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Quantum Ventilation Module

Everything you need for a 510(k) submission. Nothing you don't.