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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K240271
Device Name Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
Applicant
Linshom Medical, Inc.
2922 Excelsior Springs Court
Ellicott City,  MD  21042
Applicant Contact William Stoll
Correspondent
Linshom Medical, Inc.
2922 Excelsior Springs Court
Ellicott City,  MD  21042
Correspondent Contact William Stoll
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received01/31/2024
Decision Date 09/11/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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