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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Motility System, Capsule
510(k) Number K253569
Device Name Atmo Gas Capsule System
Applicant
Atmo Biosciences, Ltd.
436 Elgar Rd.
Box Hill,  AU 3128
Applicant Contact Ian Macfarlane
Correspondent
Atmo Biosciences, Ltd.
436 Elgar Rd.
Box Hill,  AU 3128
Correspondent Contact Allison Lockwood
Regulation Number876.1725
Classification Product Code
NYV  
Date Received11/17/2025
Decision Date 05/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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