Regulatory filing

fda_de_novo (us_fda)

FDA De Novo clearance for CMR Surgical Versius (Oct 2024). Versius Plus 510(k) also filed.

fda de novo · cleared · decided 2024-10-01

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Revision history: /regulatory-filings/cmr-versius-fda-de-novo/history
Data documentation: /data
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Key facts

Jurisdiction: us_fda
Filing type: fda de novo
Status: cleared
Filing date: 2024-10-01
Decision date: 2024-10-01
Verification posture: verified

Applicant

Covered models (1)

Versius

Sources (1)

https://www.cmrsurgical.com/

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Identity

8bf8ee7d-5989-493b-8459-a6ffa1e76d19