FDA 510(k)

KOWA DR-1a

K-Number: K190573 · 2019-06-04

Decision Date2019-06-04

Product CodeHKI

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

KOWA DR-1a 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 2019-06-04 under 510(k) 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. The listed applicant is Kowa Company , Ltd.. The 510(k) number is K190573.

When did KOWA DR-1a receive FDA 510(k) clearance?

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

Who is the listed applicant for KOWA DR-1a?

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 DR-1a?

The FDA product code for KOWA DR-1a 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 K191945KOWA nonmyd 8

Related Devices (Code: HKI)

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom Technologies K252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private Limited K250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.Ltd K250683Resolve 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.