Client Background:

The manufacturer produces devices which belongs to Class II used to measure the saturation of oxygen carried in red blood cells. The manufacturer of Class II for the non-invasive, continuous monitoring of pulse rate and the functional oxygen saturation of arterial haemoglobin (Sp02). For use in hospitals, hospital-like facilities, and intra-hospital transport environments with the pediatric and adult populations.

Client Problem:

The client was struggling to prepare 510(k) and needed immediate support. They had very less data and needed someone to help them gather the data.

ND Global Solution & Approach:

ND Global developed a 510 (k) template in accordance with the FDA Guidance. The customer received thorough support to prepare their 510 (k) file. ND Global also broadened the scope and offered advisory consultation for MDR compliance.

Project Achievements:

Based on their positive experience, the customer extended the scope of work to seek support for other devices.

Project Outcomes:

The devices received 510 (k) after the FDA reviewed and accepted them without making any observations.