The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies, Inc. with the FDA for Muse Cardiology Information System.
| Device ID | K110132 |
| 510k Number | K110132 |
| Device Name: | MUSE CARDIOLOGY INFORMATION SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. 9900 WEST INNOVATION DRIVE Wauwatosa, WI 53226 |
| Contact | Kristin Pabst |
| Correspondent | Kristin Pabst GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. 9900 WEST INNOVATION DRIVE 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 | 2011-01-18 |
| Decision Date | 2011-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682100182 | K110132 | 000 |
| 00840682107921 | K110132 | 000 |