PREGELLED DISPOSABLE ELECTRODE, SILVER-SILVER— 510(k) K865011
Substantially EquivalentLabeltape Meditect, Inc.
FDA 510(k) clearance K865011 for PREGELLED DISPOSABLE ELECTRODE, SILVER-SILVER, Substantially Equivalent on 1987-03-13. Applicant: Labeltape Meditect, Inc.. Device class: 2.
Clearance details
- Applicant
- Labeltape Meditect, 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
- Grand Rapids, MI, US
Recent devices under product code DRX
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view all- K951328 — LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORD
- K915333 — ELECTRODE USING PROMEON RG-60 SERIES GEL
- K914871 — TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL
- K912979 — HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION
- K902738 — ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH
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.