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 | K152993 |
| 510k Number | K152993 |
| 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 | Amy Yang |
| Correspondent | Amy Yang 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-13 |
| Decision Date | 2016-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195278458070 | K152993 | 000 |