FDA 510(k) Application Details - K240406

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K240406
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant Sonio
17 Rue du Faubourg Montmartre
Paris 75009 FR
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Contact Florian Akpakpa
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 02/09/2024
Decision Date 04/26/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K240406


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