AutoMIStar
K-Number: K192912 · 2019-12-31
Decision Date2019-12-31
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
AutoMIStar is a medical device manufactured by Apollo Medical Imaging Technology Pty. , Ltd.. It received FDA 510(k) clearance on 2019-12-31 under approval number K192912. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AutoMIStar?
AutoMIStar is a medical device that received FDA 510(k) clearance on 2019-12-31. It is manufactured by Apollo Medical Imaging Technology Pty. , Ltd.. The 510(k) number is K192912.
When was AutoMIStar approved by the FDA?
AutoMIStar received FDA 510(k) clearance on 2019-12-31, under approval number K192912.
What company makes AutoMIStar?
AutoMIStar is manufactured by Apollo Medical Imaging Technology Pty. , Ltd..
What is the FDA product code for AutoMIStar?
The FDA product code for AutoMIStar is LLZ.
Related Devices (Code: LLZ)
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.