Basic Information
- Primary DI
- 08809435482021
- Basic UDI-DI Code
- B-08809435482021
- Reference
- CSO-I-004-R1
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- CU Medical Systems, Inc.
Additional Description
The NFK200 is semi-automated external defibrillators (AED). If connected to a patient, it automatically acquires and analyzes the electrocardiogram (ECG) of the patient for the presence of Ventricular Fibrillation or Ventricular Tachycardia (also known as shockable rhythms). If a shockable rhythm is detected, the NFK200 automatically charges itself and then prompts the user to press the SHOCK button. When the user presses the SHOCK button after being prompted to press it, the NFK200 delivers a defibrillating shock. After delivering a shock, the NFK200 pauses to enable the user to administer cardiopulmonary resuscitation (CPR).
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12030501 | SEMI-AUTOMATIC DEFIBRILLATORS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 9805-2017-CE-KOR-NA-PS Rev. 6.0 | DNV Product Assurance AS | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).