The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies, Inc. with the FDA for Mac 5 A4/ Mac 5 A5/ Mac 5 Lite Resting Ecg Analysis System.
| Device ID | K221321 |
| 510k Number | K221321 |
| Device Name: | MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System |
| Classification | Electrocardiograph |
| Applicant | GE Medical Systems Information Technologies, Inc. 9900 Innovation Drive Wauwatosa, WI 53226 |
| Contact | Honghong Yang |
| Correspondent | Honghong Yang 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 | 2022-05-06 |
| Decision Date | 2022-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195278276124 | K221321 | 000 |
| 00195278276087 | K221321 | 000 |
| 00195278276070 | K221321 | 000 |