Name: Predicase
Price: 199 USD

K-number	K024323
Device name	CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000
Applicant	Biomedical Systems Corp.
Product code	MLO
Device class	Class II
Decision date	Jun 30, 2003
Decision	Substantially Equivalent
Regulation	870.2800

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Source

View the full FDA submission: accessdata.fda.gov

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CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000

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