Ultra Ease
FDA 510(k) K950943 · Lectec Corp.
510(k) numberK950943
Submission
- Device name
- Ultra Ease
- Applicant
- Lectec Corp.
Minnetonka, MN, US - Received
- February 16, 1995
- Decision date
- March 7, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Ultra Ease cleared by the FDA?
Ultra Ease (K950943) received a 510(k) decision of Substantially Equivalent on March 7, 1996, 385 days after the submission was received.
What is the product code of K950943?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.