The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Unity Network Patient Data Server.
Device ID | K032582 |
510k Number | K032582 |
Device Name: | UNITY NETWORK PATIENT DATA SERVER |
Classification | System, Network And Communication, Physiological Monitors |
Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
Contact | Karen Lunde |
Correspondent | Karen Lunde GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
Product Code | MSX |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-08-21 |
Decision Date | 2003-09-17 |
Summary: | summary |