Monitor, Line Isolation
The Line Isolation Monitor is a cardiovascular electrical safety device used to continuously monitor medical electrical systems for isolation faults that could pose a shock hazard to patients or clinical staff. It is classified as an FDA Class 1 device, representing the lowest level of regulatory concern, and is subject to general controls only. The product code is DRI and it is regulated under 21 CFR 870.2620 within the Cardiovascular medical specialty.
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Basic Information
- Product Code
- DRI
- Device Class
- FDA class 1
- Regulation Number
- 870.2620
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K902493 | CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR | Jul 06, 1990 | Substantially Equivalent | Datex Division Instrumentarium Corp. |
| K902492 | CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S | Jul 06, 1990 | Substantially Equivalent | Datex Division Instrumentarium Corp. |
| K822316 | HEART MONITOR BRACELET ALARM | Sep 21, 1982 | Substantially Equivalent | Hmba |
| K802326 | PRESSURE MONITORING LINES | Oct 10, 1980 | Substantially Equivalent | Stanco Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.