Name: Predicase
Price: 199 USD

K-number	K062324
Device name	MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN
Applicant	GE Healthcare
Product code	MHX
Device class	Class II
Decision date	Dec 6, 2006
Decision	Substantially Equivalent
Regulation	870.1025

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Source

View the full FDA submission: accessdata.fda.gov

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MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN

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