UROVAL, INC.

Want to know more about this Organization? Request more information now!

Filters

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

Electromyograph, Diagnostic (IKN) (2)

Premarket Exempt

No Yes

Clear

Uroval - 00852523007024 Catalog Number :

Device Description : 6' Electrode Lead Wire Set for use with the Uroval BRS System.

Device Class : 2

Duns Number: 069555565

Premarket Exempt : Yes

Product Code : IKN

Prescription Use : No

Device Count : 1

Uroval - 00852523007062 Catalog Number : BRS01

Device Description : The Uroval BRS System is used to record and display electromyogram (EMG )signals The Uroval BRS System is used to record and display electromyogram (EMG )signals. In addition, the BRS System will determine latency time intervals of the bulbocavernosus reflex (BCR). The Uroval BRS System also has report generation capabilities. The Uroval BRS System uses a probe, with a single use disposable tip to evoke a BCR response and activate recording and timing of EMG signals. The Uroval BRS System uses pre-gelled surface electrodes to monitor the muscle activity.

Device Class : 2

Duns Number: 069555565

Premarket Exempt : No

Product Code : IKN

Prescription Use : No

Device Count : 1

Previous 1 Next