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)

Workflow Box

K-Number: K181572 · 2018-07-10

Decision Date2018-07-10
Product CodeQKB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Workflow Box is a medical device manufactured by Mirada Medical, Ltd.. It received FDA 510(k) clearance on 2018-07-10 under approval number K181572. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Workflow Box?

Workflow Box is a medical device that received FDA 510(k) clearance on 2018-07-10. It is manufactured by Mirada Medical, Ltd.. The 510(k) number is K181572.

When was Workflow Box approved by the FDA?

Workflow Box received FDA 510(k) clearance on 2018-07-10, under approval number K181572.

What company makes Workflow Box?

Workflow Box is manufactured by Mirada Medical, Ltd..

What is the FDA product code for Workflow Box?

The FDA product code for Workflow Box is QKB.

Other Devices by Mirada Medical, Ltd.

Related Devices (Code: QKB)

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.