Name: Predicase
Price: 199 USD

K-number	K213490
Device name	Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P
Applicant	Ge Medical Systems Information Technologies, Inc.
Product code	MHX
Device class	Class II
Decision date	Apr 1, 2022
Decision	Substantially Equivalent
Regulation	870.1025

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P

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