510(k) K080226

NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912 by Hill-Rom Manufacturing, Inc. — Product Code HGM

K080226 is an FDA 510(k) premarket notification submitted by Hill-Rom Manufacturing, Inc. for the device "NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912". The FDA issued a decision of Substantially Equivalent on Apr 9, 2008. 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
Apr 9, 2008
Date Received
Jan 29, 2008
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 K080226. Report a data issue: hello@regdatalab.com.