Name: Predicase
Price: 199 USD

K-number	K190578
Device name	SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence
Applicant	Siemens Medical Solutions USA, Inc.
Product code	JAK
Device class	Class II
Decision date	Jun 27, 2019
Decision	Substantially Equivalent
Regulation	892.1750

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Source

View the full FDA submission: accessdata.fda.gov

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SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence

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