Acclarix Diagnostic Ultrasound System
FDA 510(k) K150999 · Edan Instruments, Inc.
510(k) numberK150999
Submission
- Device name
- Acclarix Diagnostic Ultrasound System
- Applicant
- Edan Instruments, Inc.
Shekou, CN - Received
- April 15, 2015
- Decision date
- May 6, 2015
- 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 Acclarix Diagnostic Ultrasound System cleared by the FDA?
Acclarix Diagnostic Ultrasound System (K150999) received a 510(k) decision of Substantially Equivalent on May 6, 2015, 21 days after the submission was received.
What is the product code of K150999?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.