FDA 510(K) K150313, Ablation Confirmation
FDA 510(K) K150313, Ablation Confirmation
Device Classification Name System, Image Processing, Radiological
510(k) Number K150313
Device Name Ablation Confirmation
Applicant NEUWAVE MEDICAL INC.
Regulation Number 892.2050
Classification Product Code LLZ
Date Received 02/09/2015
Decision Date 07/09/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
Total pages: 1,102
Fully redacted pages: 813
Content pages: 289
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