FDA 510(k) Application Details - K040903

Device Classification Name System, Monitoring, Perinatal

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510(K) Number K040903
Device Name System, Monitoring, Perinatal
Applicant EDAN INSTRUMENTS, INC.
1 ODELL PLAZA
YONKERS, NY 10701 US
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Contact WILLIAM STERN
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Regulation Number 884.2740

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Classification Product Code HGM
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Date Received 04/07/2004
Decision Date 09/02/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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