DRI · Monitor, Line Isolation
Cardiovascular · 21 CFR 870.2620 · Class 1
Overview
| Product Code | DRI |
|---|---|
| Device Name | Monitor, Line Isolation |
| Regulation | 21 CFR 870.2620 |
| Device Class | Class 1 |
| Review Panel | Cardiovascular |
Identification
A line isolation monitor is a device used to monitor the electrical leakage current from a power supply electrically isolated from the commercial power supply received from a utility company.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K902493 | CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR | Datex Division Instrumentarium Corp. | Jul 6, 1990 | SESE |
| K902492 | CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S | Datex Division Instrumentarium Corp. | Jul 6, 1990 | SESE |
| K822316 | HEART MONITOR BRACELET ALARM | Hmba | Sep 21, 1982 | SESE |
| K802326 | PRESSURE MONITORING LINES | Stanco Medical, Inc. | Oct 10, 1980 | SESE |
Top Applicants
- Datex Division Instrumentarium Corp. — 2 clearances
- Hmba — 1 clearance
- Stanco Medical, Inc. — 1 clearance
