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FDA 510(k) Application Details - K014094
Device Classification Name
System, Monitoring, Perinatal
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
884.2740
More FDA Info for this Regulation Number
Classification Product Code
HGM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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