K081437 is an FDA 510(k) clearance for the MAC 1600 ECG ANALYSIS SYSTEM. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Ge Medical Systems Information Technologies (Wauwatosa, US). The FDA issued a Cleared decision on July 15, 2008, 54 days after receiving the submission on May 22, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K081437 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2008 |
| Decision Date | July 15, 2008 |
| Days to Decision | 54 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 |