Name: Predicase
Price: 199 USD

K-number	K991735
Device name	MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHS
Applicant	General Electric Medical Systems Information Techn
Product code	LOS
Device class	Class unclassified
Decision date	Aug 19, 1999
Decision	Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHS

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