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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 the device name listed in this FDA 510(k) record. The listed applicant is Koya Medical, Inc.. It received FDA 510(k) clearance on 2021-09-21 under 510(k) 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. The listed applicant is Koya Medical, Inc.. The 510(k) number is K212287.

When did Dayspring Lite receive FDA 510(k) clearance?

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

Who is the listed applicant for Dayspring Lite?

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 Lite?

The FDA product code for Dayspring Lite 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.

K223228DayspringK210885Dayspring

Related Devices (Code: JOW)

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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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