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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor, physiological, patient (without arrhythmia detection or alarms)
510(k) Number K183634
Device Name Stasis Monitoring System
Applicant
Stasis Labs, Inc.
9121 Airdrome St.
los angeles,  CA  90035
Applicant Contact derek nielsen
Correspondent
510konsult LLC
754 NW Broadway, Suite 206
bend,  OR  97703
Correspondent Contact eric eggers
Regulation Number870.2300
Classification Product Code
MWI  
Date Received12/26/2018
Decision Date 04/17/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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