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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K233280
Device Name SteadyTemp
Applicant
Steadysense GmbH
Kaerntner Strasse 518
Seiersberg Pirka,  AT 8054
Applicant Contact Werner Koele
Correspondent
Borderless Meddev, LLC
7118 Teakwood Cir
Maple Grove,  MN  55369
Correspondent Contact Brodie Pedersen
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/29/2023
Decision Date 06/21/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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