Name: Predicase
Price: 199 USD

K-number	K221333
Device name	Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional
Applicant	Acumed, LLC
Product code	HWC
Device class	Class II
Decision date	Dec 29, 2022
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional

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