Decision Date2019-10-27
Product CodeDSJ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
EarlyVue VS30 is a medical device manufactured by Philips Medizin Systeme Boeblingen GmbH. It received FDA 510(k) clearance on 2019-10-27 under approval number K190624. The device is classified under product code DSJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EarlyVue VS30?
EarlyVue VS30 is a medical device that received FDA 510(k) clearance on 2019-10-27. It is manufactured by Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K190624.
When was EarlyVue VS30 approved by the FDA?
EarlyVue VS30 received FDA 510(k) clearance on 2019-10-27, under approval number K190624.
What company makes EarlyVue VS30?
EarlyVue VS30 is manufactured by Philips Medizin Systeme Boeblingen GmbH.
What is the FDA product code for EarlyVue VS30?
The FDA product code for EarlyVue VS30 is DSJ.
Other Devices by Philips Medizin Systeme Boeblingen GmbH
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Official Source
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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.