DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S Diagnostic Ultrasound System
FDA 510(k) K123185 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
510(k) numberK123185
Submission
- Device name
- DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S Diagnostic Ultrasound System
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Shenzhen, CN - Received
- October 10, 2012
- Decision date
- November 2, 2012
- 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 DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S Diagnostic Ultrasound System cleared by the FDA?
DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S Diagnostic Ultrasound System (K123185) received a 510(k) decision of Substantially Equivalent on November 2, 2012, 23 days after the submission was received.
What is the product code of K123185?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.