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subpart-b—diagnostic-devices/

Versana Balance

Page Type: Cleared 510(K)
PDF: FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number: K191792
510(k) Type: Traditional
Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
Country: United States
FDA Decision: Substantially Equivalent
Decision Date: 8/9/2019
Days to Decision: 37 days
Submission Type: Summary

FDA Browser

subpart-b—diagnostic-devices/

Versana Balance

Page Type: Cleared 510(K)
PDF: FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number: K191792
510(k) Type: Traditional
Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
Country: United States
FDA Decision: Substantially Equivalent
Decision Date: 8/9/2019
Days to Decision: 37 days
Submission Type: Summary