Pedi-Padz Radiolucent Multi-Function Pediatric Electrodes, Model 8900-1005
FDA 510(k) K040256 · Bio-Detek, Inc.
Submission
- Device name
- Pedi-Padz Radiolucent Multi-Function Pediatric Electrodes, Model 8900-1005
- Applicant
- Bio-Detek, Inc.
Pawtucket, RI, US - Received
- February 4, 2004
- Decision date
- April 9, 2004
- 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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| K040056 | Bio-Detek Electrode Adapter, Model R2001-90MKJ · Traditional | 04/09/2004SE |
| K033771 | Bio-Detek Modified Adult Multi-Function Electrode with ConnectorMKJ · Traditional | 02/27/2004SE |
| K984582 | Zoll Superpadz Adult Multi-Function Electrodes, Model 8900-XXXXMKJ · Traditional | 03/16/1999SE |
| K990106 | Zoll First Responder Padz Adult Defibrillation ElectrodesMKJ · Traditional | 02/26/1999SE |
| K981802 | Zoll Stat*Padz Adult Multi-Function Electrodes Model Number 8900-4003MKJ · Traditional | 11/25/1998SE |
Questions and answers
When was Pedi-Padz Radiolucent Multi-Function Pediatric Electrodes, Model 8900-1005 cleared by the FDA?
Pedi-Padz Radiolucent Multi-Function Pediatric Electrodes, Model 8900-1005 (K040256) received a 510(k) decision of Substantially Equivalent on April 9, 2004, 65 days after the submission was received.
What is the product code of K040256?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.