System, Signal Isolation
The Signal Isolation System is a cardiovascular electrical safety device that provides electrical isolation between a patient and monitoring or diagnostic equipment, protecting against inadvertent shock from electrical leakage currents. 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 DRJ and it is regulated under 21 CFR 870.2600 within the Cardiovascular medical specialty.
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Basic Information
- Product Code
- DRJ
- Device Class
- FDA class 1
- Regulation Number
- 870.2600
- 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 |
|---|---|---|---|---|
| K832828 | CENTURION CARDIAC DETECTOR | May 09, 1984 | Substantially Equivalent | Clinical Data Instruments, Inc. |
| K822590 | PRESSURE ISOLATION AMPLIFIER #9813 517 | Oct 04, 1982 | Substantially Equivalent | Honeywell, Inc. |
| K771685 | AMPLIFIER MODEL N5A-HIS | Sep 14, 1977 | Substantially Equivalent | Honeywell, Inc. |
| K771684 | AMPLIFIER MODEL N5A-ECG | Sep 14, 1977 | Substantially Equivalent | Honeywell, 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.