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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
Mermaid Care A/S
Hedelund 1
Norresundby,  DK DK-0400
Applicant Contact Claus Lindholt
Mermaid Care A/S
Hedelund 1
Norresundby,  DK DK-0400
Correspondent Contact Claus Lindholt
Regulation Number868.1850
Classification Product Code
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