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FDA 510(k)

KOWA nonmyd 8

K-Number: K191945 · 2019-09-10

ApplicantKowa Company , Ltd.
Decision Date2019-09-10
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KOWA nonmyd 8 is a medical device manufactured by Kowa Company , Ltd.. It received FDA 510(k) clearance on 2019-09-10 under approval number K191945. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOWA nonmyd 8?

KOWA nonmyd 8 is a medical device that received FDA 510(k) clearance on 2019-09-10. It is manufactured by Kowa Company , Ltd.. The 510(k) number is K191945.

When was KOWA nonmyd 8 approved by the FDA?

KOWA nonmyd 8 received FDA 510(k) clearance on 2019-09-10, under approval number K191945.

What company makes KOWA nonmyd 8?

KOWA nonmyd 8 is manufactured by Kowa Company , Ltd..

What is the FDA product code for KOWA nonmyd 8?

The FDA product code for KOWA nonmyd 8 is HKI.

Other Devices by Kowa Company , Ltd.

K190573KOWA DR-1a K222372Kowa SL-19

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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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