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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K220196
Device Name Steth IO Spot
Applicant
Stratoscientific
19125 N. Creek Pkwy. #120
Bothell,  WA  98011
Applicant Contact Mahesh Mulumudi
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.1875
Classification Product Code
DQD  
Date Received01/24/2022
Decision Date 03/24/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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