Bladderscan Bvi 6100
FDA 510(k) K022153 · Diagnostic Ultrasound Corp.
510(k) numberK022153
Submission
- Device name
- Bladderscan Bvi 6100
- Applicant
- Diagnostic Ultrasound Corp.
Bothell, WA, US - Received
- July 2, 2002
- Decision date
- August 15, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Bladderscan Bvi 6100 cleared by the FDA?
Bladderscan Bvi 6100 (K022153) received a 510(k) decision of Substantially Equivalent on August 15, 2002, 44 days after the submission was received.
What is the product code of K022153?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.