DRJ — System, Signal Isolation Class I
FDA product code DRJ covers "System, Signal Isolation", a Class I medical device regulated under 21 CFR 870.2600. Submissions are reviewed by the Cardiovascular panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DRJ
- Device Class
- Class I
- Regulation Number
- 870.2600
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K832828 | clinical data instruments | CENTURION CARDIAC DETECTOR | May 9, 1984 |
| K822590 | honeywell | PRESSURE ISOLATION AMPLIFIER #9813 517 | October 4, 1982 |
| K771685 | honeywell | AMPLIFIER MODEL N5A-HIS | September 14, 1977 |
| K771684 | honeywell | AMPLIFIER MODEL N5A-ECG | September 14, 1977 |