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

FDA 510(k)

GMR40

K-Number: K171085 · 2017-05-11

ApplicantNeurologica Corporation, A Subsidiary OF
Decision Date2017-05-11
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GMR40 is a medical device manufactured by Neurologica Corporation, A Subsidiary OF. It received FDA 510(k) clearance on 2017-05-11 under approval number K171085. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GMR40?

GMR40 is a medical device that received FDA 510(k) clearance on 2017-05-11. It is manufactured by Neurologica Corporation, A Subsidiary OF. The 510(k) number is K171085.

When was GMR40 approved by the FDA?

GMR40 received FDA 510(k) clearance on 2017-05-11, under approval number K171085.

What company makes GMR40?

GMR40 is manufactured by Neurologica Corporation, A Subsidiary OF.

What is the FDA product code for GMR40?

The FDA product code for GMR40 is MQB.

Related Devices (Code: MQB)

K162555EVS 4343, EVS 4343GDRTECH Corporation K162344INNOLUX RICInnolux Corporation K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai) , Ltd. K162552EVS 3643, EVS 3643GDRTECH Corporation K163019CareView 750Cw/750C X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd. K160143ClearVision ExamVue Flat Panel DetectorJpi Healthcare, Inc.

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.

↑