K050731 is an FDA 510(k) clearance for the SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM. This device is classified as a Electrocardiograph, Ambulatory (without Analysis) (Class II - Special Controls, product code MWJ).
Submitted by Ge Medical Systems Information Technologies (Milwaukee, US). The FDA issued a Cleared decision on May 19, 2005, 59 days after receiving the submission on March 21, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K050731 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 2005 |
| Decision Date | May 19, 2005 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MWJ - Electrocardiograph, Ambulatory (without Analysis) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2800 |