MEDI-TRACE 5700 RESTING ECG ELECTRODE— 510(k) K963151
Substantially EquivalentGraphic Controls Corp.
FDA 510(k) clearance K963151 for MEDI-TRACE 5700 RESTING ECG ELECTRODE, Substantially Equivalent on 1996-11-19. Applicant: Graphic Controls Corp.. Device class: 2.
Clearance details
- Applicant
- Graphic Controls Corp.
- Product code
- Code DRX
- Device class
- Class 2
- Regulation
- 21 CFR 870.2360
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Buafflo, NY, US
Recent devices under product code DRX
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- K980857 — MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE
- K972970 — MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
Adverse events under product code DRX
product code DRX- Death
- 6
- Injury
- 476
- Other
- 2
- Total
- 484
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.