Suzhou PeakSonic Medical Technology Co.,LTD.

Address:2A, West Side of Building G4, Kunshan Hi-Tech Medical Device Industrial Park,Suzhou Jiangsu,CN

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Imaging, Pulsed Echo, Ultrasonic (IYO) (2) Transducer, Ultrasonic, Diagnostic (ITX) (2)

Premarket Exempt

Clear

Bladder Scanner - 06975124100285 Catalog Number :

Device Description : Peaksonic M2-W is a hand-held portable bladder volumeter, which can be used in s Peaksonic M2-W is a hand-held portable bladder volumeter, which can be used in surgery, emergency, ICU, obstetrics, gynecology, radiotherapy, sanatorium and other departments. It can provide a basis for clinical catheterization, evaluate the residual urine after urination, and assist in the diagnosis of bladder and kidney diseases. The system is also applicable to patients with lower limb disability or loss of automatic urination function to confirm the appropriate urination time.

Device Class : 2

Duns Number: 554531949

Premarket Exempt : No

Product Code : ITX, IYO

Prescription Use : Yes

Device Count : 1

Bladder Scanner - 06975124100537 Catalog Number :

Device Description : The instrument is suitable for the measurement of bladder volume in hospitals, n The instrument is suitable for the measurement of bladder volume in hospitals, nursing homes and homes. To provide the basis for the implementation of clinical catheterization, evaluate the residual volume after micturition, and make auxiliary diagnosis for the diseases of bladder and renal function. The instrument is also suitable for people with lower body disability and loss of self urination function to master the timing of urination.