Radx System
FDA 510(k) K965203 · Electro Medical Systems, Inc.
510(k) numberK965203
Submission
- Device name
- Radx System
- Applicant
- Electro Medical Systems, Inc.
North Attleboro, MA, US - Received
- December 26, 1996
- Decision date
- March 17, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Radx System cleared by the FDA?
Radx System (K965203) received a 510(k) decision of Substantially Equivalent on March 17, 1997, 81 days after the submission was received.
What is the product code of K965203?
The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.