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510(k) K242583

AT-Patch (ATP-C130/ATP-C70) by Atsens Co., Ltd. — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2025
Date Received
August 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Magnetic Tape, Medical
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Atsens Co., Ltd.

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