K-number	K202557
Device name	Quantum Workstation 12 Elite
Applicant	Spectrum Medical , Ltd.
Product code	DRY
Device class	Class II
Decision date	Oct 2, 2020
Decision	Substantially Equivalent
Regulation	870.4330

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Source

View the full FDA submission: accessdata.fda.gov

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Quantum Workstation 12 Elite

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