SKYLINE 55
Device Facts
| Record ID | K081552 |
|---|---|
| Device Name | SKYLINE 55 |
| Applicant | Larsen & Toubro Limited |
| Product Code | MWI · Cardiovascular |
| Decision Date | Jul 31, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2300 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Regulatory Classification
Identification
A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.
