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FDA 510(k)

Koya Ripple

K-Number: K193288 · 2020-06-16

ApplicantKoya, Inc.
Decision Date2020-06-16
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Koya Ripple is a medical device manufactured by Koya, Inc.. It received FDA 510(k) clearance on 2020-06-16 under approval number K193288. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Koya Ripple?

Koya Ripple is a medical device that received FDA 510(k) clearance on 2020-06-16. It is manufactured by Koya, Inc.. The 510(k) number is K193288.

When was Koya Ripple approved by the FDA?

Koya Ripple received FDA 510(k) clearance on 2020-06-16, under approval number K193288.

What company makes Koya Ripple?

Koya Ripple is manufactured by Koya, Inc..

What is the FDA product code for Koya Ripple?

The FDA product code for Koya Ripple is JOW.

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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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