HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0— 510(k) K102263
Substantially EquivalentMckesson Information Solutions, LLC
FDA 510(k) clearance K102263 for HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0, Substantially Equivalent on 2011-05-05. Applicant: Mckesson Information Solutions, LLC.
Clearance details
- Applicant
- Mckesson Information Solutions, LLC
- Product code
- Code HGM
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Philedelphia, PA, US
Adverse events under product code HGM
product code HGM- Death
- 35
- Malfunction
- 478
- Total
- 513
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.