Name: Predicase
Price: 199 USD

K-number	K083271
Device name	BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY
Applicant	Nihon Kohden America, Inc.
Product code	MHX
Device class	Class II
Decision date	Dec 24, 2008
Decision	Substantially Equivalent
Regulation	870.1025

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Source

View the full FDA submission: accessdata.fda.gov

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BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY

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