Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Trice Medical. It received FDA 510(k) clearance on 2016-09-16 under 510(k) 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. The listed applicant is Trice Medical. The 510(k) number is K162475.

When did mi-eye 2, mi-eye 2 monitor receive FDA 510(k) clearance?

mi-eye 2, mi-eye 2 monitor received FDA 510(k) clearance on 2016-09-16, under 510(k) number K162475.

Who is the listed applicant for mi-eye 2, mi-eye 2 monitor?

The FDA 510(k) record lists Trice Medical as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Trice Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241700Tenex 2nd Generation SystemK212556mi-eye 3 needlescope with cannula, mi-tablet 3

Related Devices (Code: HRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)K250795PUREVUE™ FMSW.O.M. World of Medicine GmbHK252666Articulator Arthroscopic BurJoint Preservation Innovations, LLC

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.

↑