Search Results
Found 1 results
510(k) Data Aggregation
K Number
K061058Device Name
NEOZOLINE VENTILATION TUBES
Manufacturer
Date Cleared
2006-07-12
(86 days)
Product Code
Regulation Number
874.3880Why did this record match?
Applicant Name (Manufacturer) :
ADEPT MEDICAL LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The largest patient population are children between 4 months and 6 years of age (but not exclusively). Otological ventilation tubes are indicated for patients with:
- Chronic or recurrent otitis media with persistent effusion (OME).
- Recurrent acute otitis media.
- Acute otitis media with complications.
- Eustachian tube dysfunction resulting in one or more of the following: significant and symptomatic hearing loss, otalgia, vertigo, and tinnitus.
- Hearing loss resulting from bilateral chronic middle ear effusion.
Device Description
Neozoline Ventilation Tubes
Ask a Question
Ask a specific question about this device
Page 1 of 1