The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies, Inc. with the FDA for Mac Vu360 Resting Ecg Analysis System.
| Device ID | K173830 |
| 510k Number | K173830 |
| Device Name: | MAC VU360 Resting ECG Analysis System |
| Classification | Electrocardiograph |
| Applicant | GE Medical Systems Information Technologies, Inc. 9900 West Innovation Drive Wauwatosa, WI 53226 |
| Contact | Marcella Entwisle |
| Correspondent | Marcella Entwisle GE Medical Systems Information Technologies, Inc. 9900 West 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 | 2017-12-18 |
| Decision Date | 2018-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682125499 | K173830 | 000 |
| 00840682125307 | K173830 | 000 |
| 00840682125291 | K173830 | 000 |