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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter, Tissue Saturation
510(k) Number K254129
Device Name Spectrum-2
Applicant
Neko Health AB
Svärdvägen 19
Danderyd,  SE 182 33
Applicant Contact Per Sundström
Correspondent
Healthcare Innovation Catalysts, Inc.
8024 Summer Mill Ct.
Bethesda,  MD  20817
Correspondent Contact Brittany Valdez Nava
Regulation Number870.2700
Classification Product Code
MUD  
Date Received12/22/2025
Decision Date 05/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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