Nuwav
FDA 510(k) K081781 · Laborie Medical Technologies, Corp.
510(k) numberK081781
Submission
- Device name
- Nuwav
- Applicant
- Laborie Medical Technologies, Corp.
Williston, VT, US - Received
- June 24, 2008
- Decision date
- July 9, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
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Questions and answers
When was Nuwav cleared by the FDA?
Nuwav (K081781) received a 510(k) decision of Substantially Equivalent on July 9, 2008, 15 days after the submission was received.
What is the product code of K081781?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.