Congratulations to PACOM for obtaining 510K approval
Source: Success cases Edit: Reanny Medical Devices Management Consulting Co., Ltd. Read: 376 Date: 2024-06-18
Shenzhen Pukang Medical is a professional enterprise engaged in household medical equipment, with main products including thermometers, breast pumps, and blood pressure monitors.
Based on commercial needs, we have signed a 510K registration project for our thermometer product.
After more than a month of document preparation, we have submitted the registration application. Due to the small scale of the client, the product is developed by external solution providers.
It was difficult to provide documents in the early stages, so our consultants patiently guided the clients, providing sample essays and explanations. Ensure timely completion of relevant documents.
After submission, obtain FDA 510K approval within 6 months of the normal FDA cycle.