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510(k) K210885

Dayspring by Koya Medical, Inc. — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2021
Date Received
March 25, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sleeve, Limb, Compressible
Device Class
Class II
Regulation Number
870.5800
Review Panel
CV
Submission Type

Other clearances by Koya Medical, Inc.

  • K223228 — Dayspring (January 4, 2024)
  • K212287 — Dayspring Lite (September 21, 2021)

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  • K251086 — PnueAira (PNCU-01) (August 18, 2025)
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  • K241096 — Venera 608 Deep Vein Thrombosis (DVT) Prevention System (January 15, 2025)
  • K240499 — ARTAIRA Arterial Compression Device (AACD01) (October 11, 2024)
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