Sonic Window
FDA 510(k) K161342 · Analogic Corporation
510(k) numberK161342
Submission
- Device name
- Sonic Window
- Applicant
- Analogic Corporation
Peabody, MA, US - Received
- May 13, 2016
- Decision date
- June 15, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Sonic Window cleared by the FDA?
Sonic Window (K161342) received a 510(k) decision of Substantially Equivalent on June 15, 2016, 33 days after the submission was received.
What is the product code of K161342?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.