Name: Predicase
Price: 199 USD

K-number	K190589
Device name	Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments
Applicant	Cochlear Americas
Product code	PFO
Device class	Class II
Decision date	Jul 3, 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 OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments

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