FDA 510(k) Application Details - K060064

Device Classification Name Monitor, Ultrasonic, Nonfetal

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510(K) Number K060064
Device Name Monitor, Ultrasonic, Nonfetal
Applicant ODVI
69 RUE DE PARIS
ORSAY 91400 FR
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Contact ARMELLE LAPRELLE
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Regulation Number 892.1540

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Classification Product Code JAF
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Date Received 01/09/2006
Decision Date 04/10/2006
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



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