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ShockPulse-SE Lithotripsy System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171024
510(k) Type
Traditional
Applicant
Cybersonics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/21/2017
Days to Decision
138 days
Submission Type
Summary

ShockPulse-SE Lithotripsy System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171024
510(k) Type
Traditional
Applicant
Cybersonics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/21/2017
Days to Decision
138 days
Submission Type
Summary