Orthoceph OC100 D
FDA 510(k) K001439 · Instrumentarium Corp.
510(k) numberK001439
Submission
- Device name
- Orthoceph OC100 D
- Applicant
- Instrumentarium Corp.
Milwaukee, WI, US - Received
- May 8, 2000
- Decision date
- June 22, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Orthoceph OC100 D cleared by the FDA?
Orthoceph OC100 D (K001439) received a 510(k) decision of Substantially Equivalent on June 22, 2000, 45 days after the submission was received.
What is the product code of K001439?
The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.