Digital Ultrasonic Diagnostic Imaging System
FDA 510(k) K110999 · Edan Instruments, Inc.
510(k) numberK110999
Submission
- Device name
- Digital Ultrasonic Diagnostic Imaging System
- Applicant
- Edan Instruments, Inc.
Nanshan, Guangdong, CN - Received
- April 11, 2011
- Decision date
- April 26, 2011
- 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 Digital Ultrasonic Diagnostic Imaging System cleared by the FDA?
Digital Ultrasonic Diagnostic Imaging System (K110999) received a 510(k) decision of Substantially Equivalent on April 26, 2011, 15 days after the submission was received.
What is the product code of K110999?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.