Hewlett-Packard M2475B with 12-LEAD Option (#C90) Codemaster 100 Conitor/Defibrillator
FDA 510(k) K982025 · Hewlett-Packard Co.
Submission
- Device name
- Hewlett-Packard M2475B with 12-LEAD Option (#C90) Codemaster 100 Conitor/Defibrillator
- Applicant
- Hewlett-Packard Co.
Andover, MA, US - Received
- June 9, 1998
- Decision date
- September 4, 1998
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Traditional 510(k)
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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Questions and answers
When was Hewlett-Packard M2475B with 12-LEAD Option (#C90) Codemaster 100 Conitor/Defibrillator cleared by the FDA?
Hewlett-Packard M2475B with 12-LEAD Option (#C90) Codemaster 100 Conitor/Defibrillator (K982025) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on September 4, 1998, 87 days after the submission was received.
What is the product code of K982025?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.