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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 K190734
Device Name Linshom Respiratory Monitoring Device (LRMD)
Applicant
Linshom Management, LLC
2922 Excelsior Springs Ct.
Ellicott City,  MD  21042
Applicant Contact Ronen Feldman
Correspondent
Linshom Management, LLC
2922 Excelsior Springs Ct.
Ellicott City,  MD  21042
Correspondent Contact Ronen Feldman
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received03/21/2019
Decision Date 01/30/2020
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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