The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies, Inc. with the FDA for Mac 7 - Resting Ecg Analysis System.
| Device ID | K203786 |
| 510k Number | K203786 |
| Device Name: | MAC 7 - Resting ECG Analysis System |
| Classification | Electrocardiograph |
| Applicant | GE Medical Systems Information Technologies, Inc. 9900 Innovation Drive Wauwatosa, WI 53226 |
| Contact | Lee Bush |
| Correspondent | Lee Bush GE Medical Systems Information Technologies, Inc. 9900 Innovation Drive Wauwatosa, WI 53226 |
| Product Code | DPS |
| Subsequent Product Code | DQK |
| Subsequent Product Code | DXH |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-28 |
| Decision Date | 2021-04-30 |