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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K241662
Device Name Ultrasound Transducer Cover
Applicant
Vitrolife Sweden AB
Gustaf Werners Gata 2
Västra Frölunda,  SE 421 32
Applicant Contact Lin Huldeberg
Correspondent
Vitrolife Sweden AB
Gustaf Werners Gata 2
Se-421 32
Vastra Frolunda,  SE 42132
Correspondent Contact Lin Huldeberg
Regulation Number892.1570
Classification Product Code
ITX  
Date Received06/10/2024
Decision Date 08/30/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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