TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE— 510(k) K083861
Substantially EquivalentInteracoustics AS
FDA 510(k) clearance K083861 for TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE, Substantially Equivalent on 2009-04-09. Applicant: Interacoustics AS. Device class: 2.
Clearance details
- Applicant
- Interacoustics AS
- Product code
- Code ETY
- Device class
- Class 2
- Regulation
- 21 CFR 874.1090
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Assens, DK
Recent devices under product code ETY
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