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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 K090273
Device Name KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100
Applicant
KAI SENSORS, INC
3465 WAIALAE AVENUE
SUITE 370
HONOLULU,  HI  96816
Applicant Contact AMY DROITCOUR
Correspondent
KAI SENSORS, INC
3465 WAIALAE AVENUE
SUITE 370
HONOLULU,  HI  96816
Correspondent Contact AMY DROITCOUR
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received02/04/2009
Decision Date 06/05/2009
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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