The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Muse Cardiology Information System With Vmware.
Device ID | K083639 |
510k Number | K083639 |
Device Name: | MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE |
Classification | Computer, Diagnostic, Programmable |
Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 9900 INNOVATION DR. Wauwatosa, WI 53226 |
Contact | Larry Lepley |
Correspondent | Larry Lepley GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 9900 INNOVATION DR. Wauwatosa, WI 53226 |
Product Code | DQK |
CFR Regulation Number | 870.1425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-12-09 |
Decision Date | 2009-02-17 |
Summary: | summary |