FDA 510(k) Application Details - K231506

Device Classification Name System,Network And Communication,Physiological Monitors

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510(K) Number K231506
Device Name System,Network And Communication,Physiological Monitors
Applicant Current Health Ltd
The Stamp Office, Level 3, 10 Waterloo Place
Edinburgh EH1 3EG GB
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Contact Giovanni Maggi
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Regulation Number 870.2300

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Classification Product Code MSX
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Date Received 05/24/2023
Decision Date 08/24/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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