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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K243220
Device Name Onera STS 2 (ONERA STS 2)
Applicant
Onera B.V.
Torenallee 42-54
Eindhoven,  NL 5617BD
Applicant Contact Pieter Ermers
Correspondent
Onera B.V.
Torenallee 42-54
Eindhoven,  NL 5617BD
Correspondent Contact Pieter Ermers
Regulation Number868.2375
Classification Product Code
MNR  
Subsequent Product Code
OLV  
Date Received10/07/2024
Decision Date 07/03/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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