K-Defib/Pace Adult Electrode, Model KDP-80
FDA 510(k) K993745 · Katecho, Inc.
510(k) numberK993745
Submission
- Device name
- K-Defib/Pace Adult Electrode, Model KDP-80
- Applicant
- Katecho, Inc.
Des Moines, IA, US - Received
- November 5, 1999
- Decision date
- February 3, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K012404 | K-Defib/Pace Adult Electrode, Model KDP-85DRO · Traditional | 10/12/2001SE |
| K010543 | KM-30 TENS ElectrodeGXY · Traditional | 05/23/2001SE |
| K003228 | K-Defib/Pace Multifuction Pediatric Electrode, Model KDP-70AMKJ · Traditional | 12/14/2000SE |
| K002806 | K-Defib/Pace, Model KDP-60AMKJ · Traditional | 11/21/2000SE |
| K000870 | KM-10 TENS ElectrodeGXY · Traditional | 11/07/2000SE |
| K991007 | K-Defib/Pace Radiolucent Adult Electrode, Model KRT-60MKJ · Traditional | 08/23/1999SE |
| K981737 | K-Defib/Pace Adult Electrode Model Number KDP-60MKJ · Traditional | 12/09/1998SE |
| K954504 | K-Defib/Pace Pediatric ElectrodeMKJ · Traditional | 11/17/1995SE |
| K934692 | K-Defib/Pace Pediatric ElectrodeMKJ · Traditional | 01/24/1995SE |
| K940801 | K-KlipDRX · Traditional | 08/03/1994SE |
Questions and answers
When was K-Defib/Pace Adult Electrode, Model KDP-80 cleared by the FDA?
K-Defib/Pace Adult Electrode, Model KDP-80 (K993745) received a 510(k) decision of Substantially Equivalent on February 3, 2000, 90 days after the submission was received.
What is the product code of K993745?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.