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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, breathing frequency
510(k) Number K151940
Device Name Thora-3Di, Model T-01
Applicant
PneumaCare LIMITED
ST. JOHNS INNOVATION CENTRE, COWLEY ROAD
CAMBRIDGE,  GB CB4 0WS
Applicant Contact MARK HARWOOD
Correspondent
PneumaCare LIMITED
C/O ALACRITA, ONE BROADWAY, 14TH FLOOR, KENDALL SQUARE
CAMBRIDGE,  MA  02142
Correspondent Contact NANDINI MURTHY
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received07/14/2015
Decision Date 03/10/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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