K092369 is an FDA 510(k) clearance for the 12SL ECG ANALYSIS PROGRAM. This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MHX).
Submitted by Ge Medical Systems Information Technologies (Wauwatosa, US). The FDA issued a Cleared decision on February 24, 2010, 203 days after receiving the submission on August 5, 2009.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K092369 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2009 |
| Decision Date | February 24, 2010 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |