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Neuro Omega System, NeuroSmart System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K220553
510(k) Type
Special
Applicant
Alpha Omega Engineering Ltd.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
9/16/2022
Days to Decision
200 days
Submission Type
Summary

Neuro Omega System, NeuroSmart System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K220553
510(k) Type
Special
Applicant
Alpha Omega Engineering Ltd.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
9/16/2022
Days to Decision
200 days
Submission Type
Summary