K103765 is an FDA 510(k) clearance for the MAC 600 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 May 17, 2011, 145 days after receiving the submission on December 23, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K103765 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2010 |
| Decision Date | May 17, 2011 |
| Days to Decision | 145 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 |