The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Cic Pro Clinical Information Center Central Station.
Device ID | K032370 |
510k Number | K032370 |
Device Name: | CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION |
Classification | Detector And Alarm, Arrhythmia |
Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
Contact | Karen M Lunde |
Correspondent | Karen M Lunde GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
Product Code | DSI |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-08-01 |
Decision Date | 2003-08-13 |
Summary: | summary |