K142288 is an FDA 510(k) clearance for the MAC 800 Resting ECG Analysis System. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Ge Medical Systems China Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on December 3, 2014, 107 days after receiving the submission on August 18, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K142288 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 2014 |
| Decision Date | December 03, 2014 |
| Days to Decision | 107 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPS - Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |