MLO
- Product code
- MLO
- Device name
- Electrocardiograph, Ambulatory, With Analysis Algorithm
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.2800
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 32
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K241890 | 2025-03-21 | Philips Medizin Systeme Böblingen GmbH | Philips Holter Analysis System | |
| K240794 | 2024-11-08 | Fourth Frontier Technologies Pvt, Ltd. | Frontier X Plus |
Official FDA classification page: MLO
Classification and pathway per current FDA publications. Data from openFDA (CC0).