Couplant Warming Device
FDA 510(k) K893225 · Echo Ultrasound
510(k) numberK893225
Submission
- Device name
- Couplant Warming Device
- Applicant
- Echo Ultrasound
Lewistown, PA, US - Received
- April 27, 1989
- Decision date
- October 12, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Couplant Warming Device cleared by the FDA?
Couplant Warming Device (K893225) received a 510(k) decision of Substantially Equivalent on October 12, 1989, 168 days after the submission was received.
What is the product code of K893225?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.