Skintact Multifunctional Electrodes with DH02 Gel with Different Connectors Compatible with Different Defibrillators
FDA 510(k) K072233 · Leonhard Lang GmbH
Submission
- Device name
- Skintact Multifunctional Electrodes with DH02 Gel with Different Connectors Compatible with Different Defibrillators
- Applicant
- Leonhard Lang GmbH
Stillwater, MN, US - Received
- August 10, 2007
- Decision date
- October 5, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 870.5310
- Specialty
- Cardiovascular
This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is…
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| K073104 | Skintact and Various Other TradenamesDRX · Special | 11/16/2007SE |
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| K041883 | Skintact Multifunction Electrodes, Model DF 21MKJ · Traditional | 09/07/2004SE |
Questions and answers
When was Skintact Multifunctional Electrodes with DH02 Gel with Different Connectors Compatible with Different Defibrillators cleared by the FDA?
Skintact Multifunctional Electrodes with DH02 Gel with Different Connectors Compatible with Different Defibrillators (K072233) received a 510(k) decision of Substantially Equivalent on October 5, 2007, 56 days after the submission was received.
What is the product code of K072233?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.