FDA Product Code MLO: Electrocardiograph, Ambulatory, With Analysis Algorithm
Leading manufacturers include Fourth Frontier Technologies Pvt, Ltd. and Philips Medizin Systeme B?blingen GmbH.
FDA 510(k) Cleared Electrocardiograph, Ambulatory, With Analysis Algorithm Devices (Product Code MLO)
About Product Code MLO - Regulatory Context
510(k) Submission Activity
32 total 510(k) submissions under product code MLO since 1999, with 32 receiving FDA clearance (average review time: 195 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under MLO have taken an average of 249 days to reach a decision - up from 191 days historically. Manufacturers should account for longer review timelines in current project planning.
MLO devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →