The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies, Inc. with the FDA for Ek12 Algorithm.
| Device ID | K170155 |
| 510k Number | K170155 |
| Device Name: | EK12 Algorithm |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| 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 | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-18 |
| Decision Date | 2017-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682125895 | K170155 | 000 |