AutoMark Module
K-Number: K160218 · 2016-12-13
ApplicantSt Jude Medical
Decision Date2016-12-13
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
AutoMark Module is a medical device manufactured by St Jude Medical. It received FDA 510(k) clearance on 2016-12-13 under approval number K160218. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AutoMark Module?
AutoMark Module is a medical device that received FDA 510(k) clearance on 2016-12-13. It is manufactured by St Jude Medical. The 510(k) number is K160218.
When was AutoMark Module approved by the FDA?
AutoMark Module received FDA 510(k) clearance on 2016-12-13, under approval number K160218.
What company makes AutoMark Module?
AutoMark Module is manufactured by St Jude Medical.
What is the FDA product code for AutoMark Module?
The FDA product code for AutoMark Module is DQK.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.