The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Modification To: Muse Cardiology Information System.
| Device ID | K072502 |
| 510k Number | K072502 |
| Device Name: | MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 9900 INNAVATION DR. Wauwatosa, WI 53226 |
| Contact | Patricia Taige |
| Correspondent | Patricia Taige GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 9900 INNAVATION DR. Wauwatosa, WI 53226 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-06 |
| Decision Date | 2007-11-19 |
| Summary: | summary |