Basic Information
- Primary DI
- 08809435482014
- Basic UDI-DI Code
- B-08809435482014
- 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 NF1200 is a semi-automated external defibrillator (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 NF1200 automatically charges itself and then prompts you to press the SHOCK button. When you press the SHOCK button after being prompted to press it, the NF1200 delivers a defibrillating shock. After delivering a shock, the NF1200 automatically goes back to ECG acquisition and analysis to determine whether another shock is necessary or not.
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).