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FDA 510(k) Application Details - K231204
Device Classification Name
More FDA Info for this Device
510(K) Number
K231204
Device Name
CochlearÖ Osia« System; CochlearÖ Osia« OSI300 Implant; CochlearÖ Magnet Cassette; CochlearÖ Non-Magnetic Cassette; CochlearÖ Osia« 2(I) Sound Processor; CochlearÖ Osia« Fitting Software 2; CochlearÖ Osia« Smart App
Applicant
Cochlear
10350 Park Meadows Drive
Lone Tree, CO 80124 US
Other 510(k) Applications for this Company
Contact
Denis DiMartino
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PFO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/27/2023
Decision Date
08/18/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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