Medi-Trace Combination Defibrillation & ECG Electrode for Hewlett Packard Defibrillators
FDA 510(k) K955882 · Graphic Controls Corp.
Submission
- Device name
- Medi-Trace Combination Defibrillation & ECG Electrode for Hewlett Packard Defibrillators
- Applicant
- Graphic Controls Corp.
Buafflo, NY, US - Received
- December 28, 1995
- Decision date
- October 24, 1996
- 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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| K964279 | Softrans Intrauterine Pressure Catheter System (Iup 4000 Softrans Iupc)KXO · Traditional | 01/22/1997SE |
| K963151 | Medi-Trace 5700 Resting ECG ElectrodeDRX · Traditional | 11/19/1996SE |
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Questions and answers
When was Medi-Trace Combination Defibrillation & ECG Electrode for Hewlett Packard Defibrillators cleared by the FDA?
Medi-Trace Combination Defibrillation & ECG Electrode for Hewlett Packard Defibrillators (K955882) received a 510(k) decision of Substantially Equivalent on October 24, 1996, 301 days after the submission was received.
What is the product code of K955882?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.