The following data is part of a premarket notification filed by Mckesson Information Solutions Llc with the FDA for Horizon Perinatal Care Surveillance And Archival Model Verson 4.0.
| Device ID | K102263 |
| 510k Number | K102263 |
| Device Name: | HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0 |
| Classification | System, Monitoring, Perinatal |
| Applicant | MCKESSON INFORMATION SOLUTIONS LLC 1835 MARKET ST. 29TH FLOOR Philadelphia, PA 19103 |
| Contact | Steven B Datlof |
| Correspondent | Steven B Datlof MCKESSON INFORMATION SOLUTIONS LLC 1835 MARKET ST. 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-10 |
| Decision Date | 2011-05-05 |
| Summary: | summary |