B-Ultrasound Diagnostic System
FDA 510(k) K232895 · Contec Medical Systems Co.,Ltd
510(k) numberK232895
Submission
- Device name
- B-Ultrasound Diagnostic System
- Applicant
- Contec Medical Systems Co.,Ltd
Qinhuangdao, CN - Received
- September 18, 2023
- Decision date
- May 3, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was B-Ultrasound Diagnostic System cleared by the FDA?
B-Ultrasound Diagnostic System (K232895) received a 510(k) decision of Substantially Equivalent on May 3, 2024, 228 days after the submission was received.
What is the product code of K232895?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.