The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies, Inc. with the FDA for 12sl Ecg Analysis Program.
| Device ID | K141963 |
| 510k Number | K141963 |
| Device Name: | 12SL ECG ANALYSIS PROGRAM |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| 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 | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-18 |
| Decision Date | 2015-02-05 |
| Summary: | summary |