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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
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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