mi-eye 2, mi-eye 2 monitor
K-Number: K162475 · 2016-09-16
ApplicantTrice Medical
Decision Date2016-09-16
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
mi-eye 2, mi-eye 2 monitor is a medical device manufactured by Trice Medical. It received FDA 510(k) clearance on 2016-09-16 under approval number K162475. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the mi-eye 2, mi-eye 2 monitor?
mi-eye 2, mi-eye 2 monitor is a medical device that received FDA 510(k) clearance on 2016-09-16. It is manufactured by Trice Medical. The 510(k) number is K162475.
When was mi-eye 2, mi-eye 2 monitor approved by the FDA?
mi-eye 2, mi-eye 2 monitor received FDA 510(k) clearance on 2016-09-16, under approval number K162475.
What company makes mi-eye 2, mi-eye 2 monitor?
mi-eye 2, mi-eye 2 monitor is manufactured by Trice Medical.
What is the FDA product code for mi-eye 2, mi-eye 2 monitor?
The FDA product code for mi-eye 2, mi-eye 2 monitor is HRX.
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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.