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FDA 510(k)

Dayspring Lite

K-Number: K212287 · 2021-09-21

ApplicantKoya Medical, Inc.
Decision Date2021-09-21
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Dayspring Lite is a medical device manufactured by Koya Medical, Inc.. It received FDA 510(k) clearance on 2021-09-21 under approval number K212287. 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 Lite?

Dayspring Lite is a medical device that received FDA 510(k) clearance on 2021-09-21. It is manufactured by Koya Medical, Inc.. The 510(k) number is K212287.

When was Dayspring Lite approved by the FDA?

Dayspring Lite received FDA 510(k) clearance on 2021-09-21, under approval number K212287.

What company makes Dayspring Lite?

Dayspring Lite is manufactured by Koya Medical, Inc..

What is the FDA product code for Dayspring Lite?

The FDA product code for Dayspring Lite is JOW.

Other Devices by Koya Medical, Inc.

K210885Dayspring 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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