返回Shenzhen Pacom Medical is an enterprise specialising in home medical devices, the main products are thermometers,
breast pumps & blood pressure monitors.
Based on the business needs, we signed the 510K registration project for thermometer products.
After more than a month of data preparation, we submitted the registration application. Due to the small size of the
client, the products were developed by an external solution provider.
It was difficult to provide the documents during the preliminary process. Our consultants patiently guided the client
and provided model documents and explanations. Finally, the relevant documents were completed in time.
After the submission, FDA 510K approval was obtained in 6 months within the normal cycle of FDA.
