FDA 510(k) K213424, Jabra Enhance Plus, by GN Hearing A/S

FDA 510(k) K213424, Jabra Enhance Plus, by GN Hearing A/S

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Device Classification Name: Self-Fitting Air-Conduction Hearing Aid, Prescription
510(k) Number: K213424
Device Name: Jabra Enhance Plus
Applicant: GN Hearing A/S
Regulation Number: 874.3325
Classification Product Code: QDD
Date Received: 10/21/2021
Decision Date: 01/19/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
510k Review Panel: Ear Nose & Throat

Total number of pages: 4,408
Fully redacted pages: 3,883
Content pages: 525

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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