DELTA4
FDA 510(k) K052920 · Scandidos AB
510(k) numberK052920
Submission
- Device name
- DELTA4
- Applicant
- Scandidos AB
Uppsala, SE - Received
- October 17, 2005
- Decision date
- January 12, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was DELTA4 cleared by the FDA?
DELTA4 (K052920) received a 510(k) decision of Substantially Equivalent on January 12, 2006, 87 days after the submission was received.
What is the product code of K052920?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.