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 the device name listed in this FDA 510(k) record. The listed applicant is Mirada Medical, Ltd.. It received FDA 510(k) clearance on 2018-07-10 under 510(k) 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. The listed applicant is Mirada Medical, Ltd.. The 510(k) number is K181572.

When did Workflow Box receive FDA 510(k) clearance?

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

Who is the listed applicant for Workflow Box?

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

What is the FDA product code for Workflow Box?

The FDA product code for Workflow Box is QKB.

Other records listing Mirada Medical, Ltd. 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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.