FDA 510(k) Application Details - K080087

Device Classification Name Monitor, Ultrasonic, Fetal

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510(K) Number K080087
Device Name Monitor, Ultrasonic, Fetal
Applicant EDAN INSTRUMENTS, INC.
1 ODELL PLAZA
YONKERS, NY 10701 US
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Contact WILLIAM STERN
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Regulation Number 884.2660

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Classification Product Code KNG
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Date Received 01/11/2008
Decision Date 03/11/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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