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510(k) Data Aggregation
K Number
K102263Device Name
HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0
Manufacturer
Date Cleared
2011-05-05
(268 days)
Product Code
Regulation Number
884.2740Why did this record match?
Applicant Name (Manufacturer) :
MCKESSON INFORMATION SOLUTIONS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Horizon Perinatal Care Surveillance and Archival System is intended for use as a central monitoring system, providing fetal surveillance and monitoring of multiple obstetrical and fetal patients simultaneously and to correlate pertinent patient observations of physiological parameters.
Horizon Perinatal Care Surveillance and Archival's indications for use are:
- . Interfaces with fetal and maternal monitors to provide fetal surveillance, monitoring of labor progress, display and archiving functions
- . Allow care givers to electronically document and store patient information on obstetrical patients in a health care facility; and
- . Provides remote access to the HPC S&A system.
Device Description
The Horizon Perinatal Care Surveillance and Archival System consists of the Horizon Perinatal Care Surveillance and Archival software, which runs on standard "off-the-shell" hardware components (e.g., servers and workstations). Horizon Perinatal Care Surveillance and Archival uses standard 100 Mbps Ethernet networking technology and is coupled to industry standard fetal monitors that are legally marketed under FDA regulations. Each fetal monitor is attached to a networked computer. Horizon Perinatal Care Surveillance and Archival is able to interface with other pertinent hospital information systems.
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