K-number	K181923
Device name	Quantum Workstation 12.1
Applicant	Spectrum Medical , Ltd.
Product code	DRY
Device class	Class II
Decision date	Aug 17, 2018
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 12.1

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