SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL— 510(k) K024247
Substantially EquivalentLeonhard Lang GmbH
FDA 510(k) clearance K024247 for SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL, Substantially Equivalent on 2003-01-16. Applicant: Leonhard Lang GmbH. Device class: 2.
Clearance details
- Applicant
- Leonhard Lang GmbH
- 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
- Special
- Location
- Stillwater, MN, US
Recent devices under product code DRX
view allMore clearances from Leonhard Lang GmbH
view allAdverse 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 →
Recalls naming K024247
K-number listed on FDA's recall record- Z-0292-2016 — ECG Electrodes: 50007 Stablebase SBW55 50675 Stablebase SBW55-15 58051 Skintact W-60 50547 Stablebase SBT60 Only OUS: 50476 Skintact W-60HP E3 I 58046 Skintact T-60 I Patz K920 58688 Dahlhausen 1900000440 59629 Cardionetics CN-15-W60 58789 Lessa 99.832.02 58872 EF Medica FS 50 LG 50359Ultragel FS50LG
- Z-1350-2015 — Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60, Catalog no. 50547. To acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K024247.
Data sourced from openFDA. This site is unofficial and independent of the FDA.