AIRSTRIP REMOTE PATIENT MONITORING
Device Facts
| Record ID | K133394 |
|---|---|
| Device Name | AIRSTRIP REMOTE PATIENT MONITORING |
| Applicant | Airstrip Technologies, LP |
| Product Code | MWI · Cardiovascular |
| Decision Date | Feb 6, 2014 |
| 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.
