K-number	K181403
Device name	Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR
Applicant	GE Healthcare
Product code	OWB
Device class	Class II
Decision date	Nov 2, 2018
Decision	Substantially Equivalent
Regulation	892.1650

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View the full FDA submission: accessdata.fda.gov

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Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR

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