Orthopantomograph OP100D
FDA 510(k) K992385 · Instrumentarium Corp.
510(k) numberK992385
Submission
- Device name
- Orthopantomograph OP100D
- Applicant
- Instrumentarium Corp.
Milwaukee, WI, US - Received
- July 16, 1999
- Decision date
- September 28, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Orthopantomograph OP100D cleared by the FDA?
Orthopantomograph OP100D (K992385) received a 510(k) decision of Substantially Equivalent on September 28, 1999, 74 days after the submission was received.
What is the product code of K992385?
The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.