True Vision, True Vision II
FDA 510(k) K974542 · Medical Dynamics, Inc.
510(k) numberK974542
Submission
- Device name
- True Vision, True Vision II
- Applicant
- Medical Dynamics, Inc.
Englewood, CO, US - Received
- December 3, 1997
- Decision date
- February 17, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was True Vision, True Vision II cleared by the FDA?
True Vision, True Vision II (K974542) received a 510(k) decision of Substantially Equivalent on February 17, 1998, 76 days after the submission was received.
What is the product code of K974542?
The FDA product code is EIA – Unit, Operative Dental, a Class I (low risk) device regulated under 21 CFR 872.6640.