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NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182616
510(k) Type
Traditional
Applicant
NinePoint Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
11/2/2018
Days to Decision
42 days
Submission Type
Summary

NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182616
510(k) Type
Traditional
Applicant
NinePoint Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
11/2/2018
Days to Decision
42 days
Submission Type
Summary