FDA 510(k)

KOWA nonmyd 8

K-Number: K191945 · 2019-09-10

Decision Date2019-09-10

Product CodeHKI

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

KOWA nonmyd 8 is the device name listed in this FDA 510(k) record. The listed applicant is Kowa Company , Ltd.. It received FDA 510(k) clearance on 2019-09-10 under 510(k) 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. The listed applicant is Kowa Company , Ltd.. The 510(k) number is K191945.

When did KOWA nonmyd 8 receive FDA 510(k) clearance?

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

Who is the listed applicant for KOWA nonmyd 8?

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

What is the FDA product code for KOWA nonmyd 8?

The FDA product code for KOWA nonmyd 8 is HKI.

Other records listing Kowa Company , 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.

K222372Kowa SL-19 K190573KOWA DR-1a

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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.