510(k) K102263

HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0 by Mckesson Information Solutions, LLC — Product Code HGM

K102263 is an FDA 510(k) premarket notification submitted by Mckesson Information Solutions, LLC for the device "HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0". The FDA issued a decision of Substantially Equivalent on May 5, 2011. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2011
Date Received
August 10, 2010
Clearance Type
Traditional
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