Name: Predicase
Price: 199 USD

K-number	K230421
Device name	SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash
Applicant	Siemens Medical Solutions USA, Inc.
Product code	JAK
Device class	Class II
Decision date	Jun 16, 2023
Decision	Substantially Equivalent
Regulation	892.1750

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Source

View the full FDA submission: accessdata.fda.gov

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

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