Last synced on 19 July 2024 at 11:05 pm

HyperVue™ Imaging System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230691
510(k) Type
Traditional
Applicant
SpectraWAVE Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/7/2023
Days to Decision
86 days
Submission Type
Summary

HyperVue™ Imaging System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230691
510(k) Type
Traditional
Applicant
SpectraWAVE Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/7/2023
Days to Decision
86 days
Submission Type
Summary