Cranial 4Pi Immobilization
FDA 510(k) K202050 · Brainlab AG
510(k) numberK202050
Submission
- Device name
- Cranial 4Pi Immobilization
- Applicant
- Brainlab AG
Munich, DE - Received
- July 24, 2020
- Decision date
- August 19, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Cranial 4Pi Immobilization cleared by the FDA?
Cranial 4Pi Immobilization (K202050) received a 510(k) decision of Substantially Equivalent on August 19, 2020, 26 days after the submission was received.
What is the product code of K202050?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.