The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Modification To Dash 2500 Patient Monitor.
Device ID | K090702 |
510k Number | K090702 |
Device Name: | MODIFICATION TO DASH 2500 PATIENT MONITOR |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
Contact | David Wahlig |
Correspondent | David Wahlig GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
Product Code | MHX |
Subsequent Product Code | DPS |
Subsequent Product Code | DQA |
Subsequent Product Code | DXN |
Subsequent Product Code | FFL |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-03-17 |
Decision Date | 2009-04-15 |
Summary: | summary |