K-number	K240864
Device name	PacePro Wire
Applicant	Opsens, Inc.
Product code	DQX
Device class	Class II
Decision date	May 24, 2024
Decision	Substantially Equivalent
Regulation	870.1330

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Source

View the full FDA submission: accessdata.fda.gov

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PacePro Wire

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