TRACE RITE SOLID GEL ECG ELECTRODES— 510(k) K964213
Substantially EquivalentBio-Detek, Inc.
FDA 510(k) clearance K964213 for TRACE RITE SOLID GEL ECG ELECTRODES, Substantially Equivalent on 1996-11-25. Applicant: Bio-Detek, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio-Detek, Inc.
- 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
- Pawtucket, RI, US
Recent devices under product code DRX
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- K133441 — ONESTEP CPR II MULTI-FUNCTION ELECTRODE
- K100565 — DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325
- K071321 — POCKETCPR
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.