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510(k) K250940

Atmo Gas Capsule System by Atmo Biosciences, Ltd. — Product Code NYV

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 26, 2025
Date Received: March 28, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Gastrointestinal Motility System, Capsule
Device Class: Class II
Regulation Number: 876.1725
Review Panel: GU
Submission Type

Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders.