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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 the device name listed in this FDA 510(k) record. The listed applicant is Kowa Company , Ltd.. It received FDA 510(k) clearance on 2022-11-21 under 510(k) 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. The listed applicant is Kowa Company , Ltd.. The 510(k) number is K222372.

When did Kowa SL-19 receive FDA 510(k) clearance?

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

Who is the listed applicant for Kowa SL-19?

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 SL-19?

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

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.

K191945KOWA nonmyd 8K190573KOWA DR-1a

Related Devices (Code: HJO)

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.

K253834VISUREF 600Carl Zeiss Vision GmbHK231760HP-OCT (HP-OCT)Cylite Pty. , Ltd.K193188MiiS Horus Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis)K182306Sunkingdom Slit LampChongqing Sunkingdom Medical Instrument Co., Ltd.K173771IOLMaster 700Carl Zeiss Meditec, AGK171877SLM-1ER, SLM-2ER, SLM-3ERChongqing Kanghua Ruiming S&T Co., Ltd.

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.

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