Basic Information
- Primary DI
- 08809435481000
- Basic UDI-DI Code
- B-08809435481000
- 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 CU-SP1 series 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 CU-SP1 series automatically charges themselves and then prompts the user to press the SHOCK button. When the user presses the SHOCK button after being prompted to press it, the CU-SP1 series delivers a defibrillating shock. After delivering a shock, the CU-SP1 series 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).