DC-7 Diagnostic Ultrasound System
FDA 510(k) K101041 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
510(k) numberK101041
Submission
- Device name
- DC-7 Diagnostic Ultrasound System
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Shenzhen, CN - Received
- April 14, 2010
- Decision date
- April 30, 2010
- 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-7 Diagnostic Ultrasound System cleared by the FDA?
DC-7 Diagnostic Ultrasound System (K101041) received a 510(k) decision of Substantially Equivalent on April 30, 2010, 16 days after the submission was received.
What is the product code of K101041?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.