K173830 is an FDA 510(k) clearance for the MAC VU360 Resting ECG Analysis System. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Ge Medical Systems Information Technologies, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on September 18, 2018, 274 days after receiving the submission on December 18, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K173830 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 2017 |
| Decision Date | September 18, 2018 |
| Days to Decision | 274 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPS - Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |