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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 K221555
Device Name Dozee VS
Applicant
Turtle Shell Technologies Private Limited
#40, City Centre, Ground and Mezzanine Floor,
CMH Road, Indiranagar
Bengaluru,  IN 560038
Applicant Contact Gaurav Parchani
Correspondent
Hammond Clinical Trial Consulting, LLC
5737 40th Ave NE
Seattle,  WA  98105
Correspondent Contact David Hammond
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received05/31/2022
Decision Date 12/15/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Clinical Trials NCT05153460
Reviewed by Third Party No
Combination Product No
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