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FDA 510(k)

SKR 4000

K-Number: K191645 · 2019-08-16

ApplicantKonica Minolta, Inc.
Decision Date2019-08-16
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SKR 4000 is a medical device manufactured by Konica Minolta, Inc.. It received FDA 510(k) clearance on 2019-08-16 under approval number K191645. 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 SKR 4000?

SKR 4000 is a medical device that received FDA 510(k) clearance on 2019-08-16. It is manufactured by Konica Minolta, Inc.. The 510(k) number is K191645.

When was SKR 4000 approved by the FDA?

SKR 4000 received FDA 510(k) clearance on 2019-08-16, under approval number K191645.

What company makes SKR 4000?

SKR 4000 is manufactured by Konica Minolta, Inc..

What is the FDA product code for SKR 4000?

The FDA product code for SKR 4000 is MQB.

Other Devices by Konica Minolta, Inc.

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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.

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