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FDA 510(k)

KOWA NONMYD WX

K-Number: K101628 · 2011-01-26

ApplicantKowa Co. , Ltd.
Decision Date2011-01-26
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KOWA NONMYD WX is the device name listed in this FDA 510(k) record. The listed applicant is Kowa Co. , Ltd.. It received FDA 510(k) clearance on 2011-01-26 under 510(k) number K101628. 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 WX?

KOWA NONMYD WX is a medical device that received FDA 510(k) clearance on 2011-01-26. The listed applicant is Kowa Co. , Ltd.. The 510(k) number is K101628.

When did KOWA NONMYD WX receive FDA 510(k) clearance?

KOWA NONMYD WX received FDA 510(k) clearance on 2011-01-26, under 510(k) number K101628.

Who is the listed applicant for KOWA NONMYD WX?

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

What is the FDA product code for KOWA NONMYD WX?

The FDA product code for KOWA NONMYD WX is HKI.

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Other records listing Kowa Co. , 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.

K112330KOWA VX-20K091098KOWAGENESIS-DFK091039KOWA, FM-600, MODEL LSS50K091683KOWA VX-10 AK083387MODIFICATION TO KOWA NONMYD ALPHA-DIIIK082767KOWA NONMYD ALPHA-DIII

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Related Devices (Code: HKI)

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K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, Inc.

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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