E-Statis 40 System
FDA 510(k) K090937 · Scican , Ltd.
510(k) numberK090937
Submission
- Device name
- E-Statis 40 System
- Applicant
- Scican , Ltd.
Toronto, CA - Received
- April 3, 2009
- Decision date
- July 24, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was E-Statis 40 System cleared by the FDA?
E-Statis 40 System (K090937) received a 510(k) decision of Substantially Equivalent on July 24, 2009, 112 days after the submission was received.
What is the product code of K090937?
The FDA product code is EBW – Controller, Foot, Handpiece And Cord, a Class I (low risk) device regulated under 21 CFR 872.4200.