Successful conclusion丨U.S.A.QSR 820 system and 510K registration training topics

On 2nd September 2021, the 2-day "US QSR 820 System and 510K Registration Training", organised by Shenzhen Association for the Promotion of Quality Management of Medical Devices, came to a successful end in the lecture hall of Mindray Company.This special training is jointly organised by Shenzhen Medical Device Quality Management Promotio···

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Good News:Congratulations to KWL Wrist Sphygmomanometer for obtaining K No.

Congratulations to KWL for successfully obtaining the 510(K) approval for the wrist sphygmomanometer. This wrist sphygmomanometer took more than two months from application to approval, and was approved after one issuance of corrective actions. Several of the issued corrections were mainly related to third-party test reports and software documentat···

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Taikang Medical Doppler Fetal Heart Monitor Receives FDA 510K Clearance Approval

At the beginning of 2022, received the results of the project - Taikang Medical Doppler Fetal Heart Monitor received FDA 510K clearance approval with K number 211940.The client is a start-up medical device company located in Pingshan. The project is an FDA510K approved project applied to the US. The client attaches great importance to it, and after···

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MIAO BANG Cervical Spine Therapeutic Device Receives NMPA Registration Approval

Cervical spine therapeutic instrument is emerging in the last three years, which is more suitable for the white-collar class. In recent years, brands with better operation have been emerging, such as SKG and Pango. The promotion of cervical spine therapeutic instrument focuses on the fashionable appearance, but the performance is the key to get a g···

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Lead New Finger Clip Oximeter Receives FDA 510K Clearance Approval K210305

Finger-clip oximetry is a prescription medical device used in the United States to measure blood oxygen saturation, SpO2, and pulse oximetry by non-invasively measuring the fingertip area of the finger.Since the haemoglobin cells in the blood, the two types of haemoglobin, oxygenated haemoglobin (HbO2) and reduced haemoglobin (Hb), are differential···

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RONG FENG Breast Pump Receives FDA 510K Clearance Approval K212884

RONG FENG Breast Pump Receives FDA 510K Clearance Approval K212884.Electric breast pump in the United States belongs to the second category of medical. The product needs to comply with the FDA requirements for medical devices. The purpose of an electric breast pump is to allow a nursing woman to express and collect milk from her breasts. It is···

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