K-number	K191013
Device name	Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option
Applicant	Welch Allyn, Inc.
Product code	BZG
Device class	Class II
Decision date	Sep 10, 2019
Decision	Substantially Equivalent
Regulation	868.1840

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Source

View the full FDA submission: accessdata.fda.gov

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Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option

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