Skintact, various other tradenames
FDA 510(k) K142803 · Leonhard Lang GmbH
510(k) numberK142803
Submission
- Device name
- Skintact, various other tradenames
- Applicant
- Leonhard Lang GmbH
Innsbruck, AT - Received
- September 29, 2014
- Decision date
- December 2, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| 510(k) | Device | Decision |
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| K140500 | SkintactGEI · Traditional | 07/29/2014SE |
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| K081371 | Skintact Pediatric Multifunction Electrodes with DH03 GelMKJ · Traditional | 09/24/2008SE |
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| K073104 | Skintact and Various Other TradenamesDRX · Special | 11/16/2007SE |
| K072233 | Skintact Multifunctional Electrodes with DH02 Gel with Different Connectors Compatible…MKJ · Special | 10/05/2007SE |
| K063161 | Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 GelGEI · Special | 11/21/2006SE |
| K041883 | Skintact Multifunction Electrodes, Model DF 21MKJ · Traditional | 09/07/2004SE |
Questions and answers
When was Skintact, various other tradenames cleared by the FDA?
Skintact, various other tradenames (K142803) received a 510(k) decision of Substantially Equivalent on December 2, 2014, 64 days after the submission was received.
What is the product code of K142803?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.