FDA 510(k) Application Details - K014094

Device Classification Name System, Monitoring, Perinatal

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510(K) Number K014094
Device Name System, Monitoring, Perinatal
Applicant HILL-ROM MANUFACTURING, INC.
11000 REGENCY PKWY.
WEST TOWER, SUITE 205
CARY, NC 27511 US
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Contact CINDY L CROSBY
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Regulation Number 884.2740

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Classification Product Code HGM
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Date Received 12/12/2001
Decision Date 01/11/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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