Congratulations to Ruini for obtaining FDA 510 (K) approval for the electric nasal cannula within 2 months, once again breaking the record for the fastest FDA 510 (K) approval in the United States!

Congratulations to Ruini for obtaining FDA 510 (K) approval for the electric nasal cannula in the United States within 2 months, once again breaking the record for fast FDA 510 (K) approval in the United States!

Electric nasal suction devices generally consist of a main body and suction components, and are a product used to remove nasal secretions and mucus from children. Regulate according to medical devices in the United States.

Ryan Ni was commissioned by a client to handle their company's electric nose wash FDA510 (K) in April 2022. After obtaining the product input information, complete the FDA 510 (K) application materials and submit the complete set of application materials to the FDA official on August 23, 2022. The entire review process was very smooth, and during the interactive review, explanations were given for several mistakes and areas that the auditor was unclear about, but no other issues were raised. Received an official approval letter from the FDA on October 21, 2022. The entire submission to approval process takes no more than 2 months.

Ruini lives up to the customer's trust! Accurately grasping product features and mastering FDA regulatory requirements are the conditions for quickly obtaining FDA 510 (K) approval. The concept of professionalism, focus, and dedication is the key to achieving certification success.