K-number	K211207
Device name	Diacare 7000
Applicant	Globus Sport and Health Technologies, LLC
Product code	PBX
Device class	Class II
Decision date	Jun 6, 2022
Decision	Substantially Equivalent
Regulation	878.4400

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Source

View the full FDA submission: accessdata.fda.gov

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Diacare 7000

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