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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Predicted Values, Pulmonary Function
510(k) Number K260242
Device Name CPETWise Platform
Applicant
Medibyt , Ltd.
Greenwork
Yakum,  IL 6097200
Applicant Contact Or Inbar
Correspondent
Beanstock Consulting
8885 Rio San Diego Dr. #237
San Diego,  CA  92108
Correspondent Contact Shawnnah Monterrey
Regulation Number868.1890
Classification Product Code
BTY  
Subsequent Product Codes
BZC   DQK  
Date Received01/26/2026
Decision Date 08/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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