FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
MULTI-FUNCTION DEFIBRILLATION ELECTRODE
K Number: K002079
·
Decision Feb 22, 2001
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
227
Applicant Total
7
Review Days
227
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Basic Information
- Device Name
- MULTI-FUNCTION DEFIBRILLATION ELECTRODE
- K Number
- K002079
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.5310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medicotest A/S
- Date Received
- July 10, 2000
- Decision Date
- February 22, 2001
- Product Code
- MKJ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | FDA class 3 | Cardiovascular |
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Other Clearances by Medicotest A/S
| K Number | Device Name | ||
|---|---|---|---|
| K020382 | BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA | Jun 28, 2002 | Substantially Equivalent |
| K020907 | NEUROLINE, SUBDERMAL NEEDLE ELECTRODES | Jun 14, 2002 | Substantially Equivalent |
| K001869 | DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE | Sep 18, 2000 | Substantially Equivalent |
| K983689 | BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES | Jan 15, 1999 | Substantially Equivalent |
| K973529 | NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES | Nov 20, 1997 | Substantially Equivalent |
| K965194 | MEDICOM, TENS ELECTRODES | Mar 6, 1997 | Substantially Equivalent |