Padscan HD Series Bladder Scanner
FDA 510(k) K131227 · Carenoso Technology Co., Ltd.
510(k) numberK131227
Submission
- Device name
- Padscan HD Series Bladder Scanner
- Applicant
- Carenoso Technology Co., Ltd.
Dandong, Liaoning, CN - Received
- April 30, 2013
- Decision date
- July 12, 2013
- 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 Padscan HD Series Bladder Scanner cleared by the FDA?
Padscan HD Series Bladder Scanner (K131227) received a 510(k) decision of Substantially Equivalent on July 12, 2013, 73 days after the submission was received.
What is the product code of K131227?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.