MLC · Monitor, St Segment
Cardiovascular · 21 CFR 870.2340 · Class 2
Overview
| Product Code | MLC |
|---|---|
| Device Name | Monitor, St Segment |
| Regulation | 21 CFR 870.2340 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K993826 | NARKOMED 6000 | Draeger Medical, Inc. | Mar 23, 2000 | SESE |
| K926099 | DATASCOPE 6000 MONITOR | Datascope Corp. | Aug 6, 1993 | SESE |
Top Applicants
- Datascope Corp. — 1 clearance
- Draeger Medical, Inc. — 1 clearance
