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FDA 510(k)

KOWA DR-1a

K-Number: K190573 · 2019-06-04

ApplicantKowa Company , Ltd.
Decision Date2019-06-04
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KOWA DR-1a is a medical device manufactured by Kowa Company , Ltd.. It received FDA 510(k) clearance on 2019-06-04 under approval number K190573. 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 DR-1a?

KOWA DR-1a is a medical device that received FDA 510(k) clearance on 2019-06-04. It is manufactured by Kowa Company , Ltd.. The 510(k) number is K190573.

When was KOWA DR-1a approved by the FDA?

KOWA DR-1a received FDA 510(k) clearance on 2019-06-04, under approval number K190573.

What company makes KOWA DR-1a?

KOWA DR-1a is manufactured by Kowa Company , Ltd..

What is the FDA product code for KOWA DR-1a?

The FDA product code for KOWA DR-1a is HKI.

Other Devices by Kowa Company , Ltd.

K191945KOWA nonmyd 8 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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