K073625 is an FDA 510(k) clearance for the MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Ge Healthcare Systems Information Technologies (Wauwatosa, US). The FDA issued a Cleared decision on January 25, 2008, 30 days after receiving the submission on December 26, 2007.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K073625 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2007 |
| Decision Date | January 25, 2008 |
| Days to Decision | 30 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 |