Dayspring— 510(k) K210885

Substantially Equivalent

Koya Medical, Inc.

FDA 510(k) clearance K210885 for Dayspring, Substantially Equivalent on 2021-04-23. Applicant: Koya Medical, Inc.. Device class: 2.

Clearance details

Applicant: Koya Medical, Inc.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2021-03-25
Decision date: 2021-04-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Oakland, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.