Panels › Cardiovascular › Product code MLO · Class 2
Electrocardiograph, Ambulatory, With Analysis Algorithm
Regulation 870.2800
1510(k)s in 12 months (33 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in MLO
| Company | 510(k)s | Recalls |
|---|---|---|
| Agilent Technologies | 3 | 0 |
| Inovise Medical, Inc. | 3 | 0 |
| Baxter Healthcare Corporation | 0 | 2 |
| Galix Biomedical Instrumentation, Inc. | 2 | 0 |
| Norav Medical , Ltd. | 2 | 0 |
| Novacor | 2 | 0 |
| Zymed Medical Instrumentation | 2 | 0 |
| Biomedical Systems Corp. | 1 | 0 |
| Bittium Biosignals , Ltd. | 1 | 0 |
| Brentwood Medical Technology Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2024 | Baxter Healthcare Corporation Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph Open, Classified |
MLO | K004017 |
| Nov 7, 2024 | Baxter Healthcare Corporation Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring Open, Classified |
MLO | K004017 |
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