K-number	K201921
Device name	Spacelabs Lifescreen PRO Analyzer
Applicant	Spacelabs Healthcare, Ltd.
Product code	DQK
Device class	Class II
Decision date	Mar 26, 2021
Decision	Substantially Equivalent
Regulation	870.1425

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Source

View the full FDA submission: accessdata.fda.gov

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Spacelabs Lifescreen PRO Analyzer

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