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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Monitoring (W/Wo Alarm)
510(k) Number K192584
Device Name BEACON Caresystem Model 00002144
Applicant
Mermaid Care A/S
Hedelund 1
Norresundby,  DK DK-0400
Applicant Contact Claus Lindholt
Correspondent
Mermaid Care A/S
Hedelund 1
Norresundby,  DK DK-0400
Correspondent Contact Claus Lindholt
Regulation Number868.1850
Classification Product Code
BZK  
Date Received09/19/2019
Decision Date 12/18/2019
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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