Name: Predicase
Price: 199 USD

K-number	K201949
Device name	Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series
Applicant	Nihon Kohden Corporation
Product code	KOI
Device class	Class II
Decision date	May 2, 2021
Decision	Substantially Equivalent
Regulation	868.2775

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Source

View the full FDA submission: accessdata.fda.gov

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Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series

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