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Orion LifeSpan MEG

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191785
510(k) Type
Traditional
Applicant
Compumedics Limited
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
2/14/2020
Days to Decision
226 days
Submission Type
Summary

Orion LifeSpan MEG

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191785
510(k) Type
Traditional
Applicant
Compumedics Limited
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
2/14/2020
Days to Decision
226 days
Submission Type
Summary