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FDA 510(k)

Dayspring

K-Number: K210885 · 2021-04-23

ApplicantKoya Medical, Inc.
Decision Date2021-04-23
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Dayspring is a medical device manufactured by Koya Medical, Inc.. It received FDA 510(k) clearance on 2021-04-23 under approval number K210885. 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 Dayspring?

Dayspring is a medical device that received FDA 510(k) clearance on 2021-04-23. It is manufactured by Koya Medical, Inc.. The 510(k) number is K210885.

When was Dayspring approved by the FDA?

Dayspring received FDA 510(k) clearance on 2021-04-23, under approval number K210885.

What company makes Dayspring?

Dayspring is manufactured by Koya Medical, Inc..

What is the FDA product code for Dayspring?

The FDA product code for Dayspring is JOW.

Other Devices by Koya Medical, Inc.

K212287Dayspring Lite K223228Dayspring

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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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