Bladderscan Bvi 5000
FDA 510(k) K955942 · Diagnostic Ultrasound Corp.
510(k) numberK955942
Submission
- Device name
- Bladderscan Bvi 5000
- Applicant
- Diagnostic Ultrasound Corp.
Redmond, WA, US - Received
- December 26, 1995
- Decision date
- March 15, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K911166 | Diagnostic Ultrasound/Uro-Gyn Ud 511DXT · Traditional | 08/15/1991SE |
| K911125 | Diagnostic Ultrasound/Uro-Gyn Ups 2020FAP · Traditional | 08/15/1991SE |
Questions and answers
When was Bladderscan Bvi 5000 cleared by the FDA?
Bladderscan Bvi 5000 (K955942) received a 510(k) decision of Substantially Equivalent on March 15, 1996, 80 days after the submission was received.
What is the product code of K955942?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.