Name: Predicase
Price: 199 USD

K-number	K182196
Device name	Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth
Applicant	Imediplus, Inc.
Product code	DQD
Device class	Class II
Decision date	Sep 11, 2018
Decision	Substantially Equivalent
Regulation	870.1875

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Source

View the full FDA submission: accessdata.fda.gov

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Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth

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