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NvisionVLE Low-profile Optical Probe

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191117
510(k) Type
Traditional
Applicant
NinePoint Medical, Inc
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
7/19/2019
Days to Decision
84 days
Submission Type
Summary

NvisionVLE Low-profile Optical Probe

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191117
510(k) Type
Traditional
Applicant
NinePoint Medical, Inc
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
7/19/2019
Days to Decision
84 days
Submission Type
Summary