Name: Predicase
Price: 199 USD

K-number	K213972
Device name	Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX
Applicant	Ge Healthcare Information Technologies, Inc.
Product code	DQK
Device class	Class II
Decision date	Feb 17, 2022
Decision	Substantially Equivalent
Regulation	870.1425

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX

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