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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 K211387
Device Name Breathe Easy Mobile Respiratory Monitor (MRM)
Applicant
Sound Life Sciences, Inc.
Startup Hall, Box 354625, 1100 NE Campus Parkway, Suite 200
Seattle,  WA  98195 -4625
Applicant Contact Kamal Shah
Correspondent
Medical Device Academy, Inc.
345 Lincoln Hill Road
Shrewsbury,  VT  05738
Correspondent Contact Robert Packard
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received05/05/2021
Decision Date 11/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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