Name: Predicase
Price: 199 USD

K-number	K230346
Device name	Voluson SWIFT; Voluson SWIFT+
Applicant	Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC
Product code	IYN
Device class	Class II
Decision date	Jun 20, 2023
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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Voluson SWIFT; Voluson SWIFT+

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