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Neuro Omega System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171581
510(k) Type
Traditional
Applicant
Alpha Omega Engineering Ltd,
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
12/22/2017
Days to Decision
205 days
Submission Type
Summary

Neuro Omega System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171581
510(k) Type
Traditional
Applicant
Alpha Omega Engineering Ltd,
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
12/22/2017
Days to Decision
205 days
Submission Type
Summary