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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 the device name listed in this FDA 510(k) record. The listed applicant is Koya Medical, Inc.. It received FDA 510(k) clearance on 2021-04-23 under 510(k) 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. The listed applicant is Koya Medical, Inc.. The 510(k) number is K210885.

When did Dayspring receive FDA 510(k) clearance?

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

Who is the listed applicant for Dayspring?

The FDA 510(k) record lists Koya Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dayspring?

The FDA product code for Dayspring is JOW.

Other records listing Koya Medical, Inc. 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.

K223228DayspringK212287Dayspring Lite

Related Devices (Code: 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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