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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 K233953
Device Name Makani Science™ Respiration Monitoring System
Applicant
Makani Science, Inc.
5270 California Ave.
Suite 300
Irvine,  CA  92617
Applicant Contact Michael Chu
Correspondent
Speed TO Market, Inc.
P.O. Box 3018
Nederland,  CO  80466
Correspondent Contact Thomas Kroenke
Regulation Number868.2375
Classification Product Code
BZQ  
Subsequent Product Code
BZK  
Date Received12/15/2023
Decision Date 03/28/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT06000852
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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