FDA 510(K) K150313, Ablation Confirmation

FDA 510(K) K150313, Ablation Confirmation

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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

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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