Orthoceph OC100
FDA 510(k) K930338 · Instrumentarium Corp.
510(k) numberK930338
Submission
- Device name
- Orthoceph OC100
- Applicant
- Instrumentarium Corp.
Tuusula, FI - Received
- January 25, 1993
- Decision date
- April 27, 1993
- 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 cleared by the FDA?
Orthoceph OC100 (K930338) received a 510(k) decision of Substantially Equivalent on April 27, 1993, 92 days after the submission was received.
What is the product code of K930338?
The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.