FDA 510(k), K181363, EcoVue Sterile and Non-Sterile Ultrasound Gels

FDA 510(k), K181363, EcoVue Sterile and Non-Sterile Ultrasound Gels

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510(K) Number: K181363
Device Name: EcoVue Sterile and Non-Sterile Ultrasound Gels
Manufacturer: HR Pharmaceuticals, Inc.
Device Classification Name: Media, Coupling, Ultrasound
Regulation Number: 892.1570
Classification Product Code: MUI
Date Received: 05/23/2018
Decision Date: 06/13/2018
Regulation Medical Specialty: Radiology

Total pages: 1,460
Fully redacted pages: 1,160
Content pages: 300

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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