Modification to Focus
FDA 510(k) K022630 · Instrumentarium Corp.
510(k) numberK022630
Submission
- Device name
- Modification to Focus
- Applicant
- Instrumentarium Corp.
Milwaukee, WI, US - Received
- August 7, 2002
- Decision date
- October 9, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Modification to Focus cleared by the FDA?
Modification to Focus (K022630) received a 510(k) decision of Substantially Equivalent on October 9, 2002, 63 days after the submission was received.
What is the product code of K022630?
The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.