DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD— 510(k) K960329
Substantially EquivalentContour Medical Technology, Inc.
FDA 510(k) clearance K960329 for DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD, Substantially Equivalent on 1996-07-02. Applicant: Contour Medical Technology, Inc.. Device class: 3.
Clearance details
- Applicant
- Contour Medical Technology, Inc.
- Product code
- Code MKJ
- Device class
- Class 3
- Regulation
- 21 CFR 870.5310
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lavergne, TN, US
Recent devices under product code MKJ
view allMore clearances from Contour Medical Technology, Inc.
view allAdverse events under product code MKJ
product code MKJ- Death
- 961
- Injury
- 1,070
- Malfunction
- 90,719
- Other
- 8
- Total
- 92,758
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 K960329
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K960329.
Data sourced from openFDA. This site is unofficial and independent of the FDA.