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510(k) K243183

RTMsense Respiratory Monitoring System by Rtm Vital Signs, LLC — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2025
Date Received
September 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Breathing Frequency
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

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