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510(k) K192584

BEACON Caresystem Model 00002144 by Mermaid Care A/S — Product Code BZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2019
Date Received
September 19, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Monitoring (W/Wo Alarm)
Device Class
Class II
Regulation Number
868.1850
Review Panel
AN
Submission Type

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