510(k) K014094

MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM by Hill-Rom Manufacturing, Inc. — Product Code HGM

K014094 is an FDA 510(k) premarket notification submitted by Hill-Rom Manufacturing, Inc. for the device "MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on Jan 11, 2002. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Hill-Rom Manufacturing, Inc. has 3 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 11, 2002
Date Received
Dec 12, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device classification

Device Name
System, Monitoring, Perinatal
Device Class
Class II
Regulation Number
884.2740
Review Panel
OB
Submission Type
510(k)

Source: FDA 510(k) database entry for K014094. Report a data issue: hello@regdatalab.com.