K-number	K110266
Device name	MAC 5500 HD, MAC 3500
Applicant	Ge Medical Systems Information Technologies, Inc.
Product code	DPS
Device class	Class II
Decision date	Apr 29, 2011
Decision	Substantially Equivalent
Regulation	870.2340

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Source

View the full FDA submission: accessdata.fda.gov

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MAC 5500 HD, MAC 3500

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