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510(k) K190734

Linshom Respiratory Monitoring Device (LRMD) by Linshom Management, LLC — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2020
Date Received
March 21, 2019
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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