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FDA 510(k)

Kowa SL-19

K-Number: K222372 · 2022-11-21

ApplicantKowa Company , Ltd.
Decision Date2022-11-21
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Kowa SL-19 is a medical device manufactured by Kowa Company , Ltd.. It received FDA 510(k) clearance on 2022-11-21 under approval number K222372. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kowa SL-19?

Kowa SL-19 is a medical device that received FDA 510(k) clearance on 2022-11-21. It is manufactured by Kowa Company , Ltd.. The 510(k) number is K222372.

When was Kowa SL-19 approved by the FDA?

Kowa SL-19 received FDA 510(k) clearance on 2022-11-21, under approval number K222372.

What company makes Kowa SL-19?

Kowa SL-19 is manufactured by Kowa Company , Ltd..

What is the FDA product code for Kowa SL-19?

The FDA product code for Kowa SL-19 is HJO.

Other Devices by Kowa Company , Ltd.

K191945KOWA nonmyd 8 K190573KOWA DR-1a

Related Devices (Code: HJO)

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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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