Name: Predicase
Price: 199 USD

K-number	K191921
Device name	Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments
Applicant	Cochlear Americas
Product code	PFO
Device class	Class II
Decision date	Nov 15, 2019
Decision	Substantially Equivalent
Regulation	874.3340

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Source

View the full FDA submission: accessdata.fda.gov

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Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments

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