FDA 510(k) Applications for Medical Device Product Code: PFO ()

FDA 510(k) Applications for Medical Device Product Code "PFO"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K231204	Cochlear	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	08/18/2023
K220922	Cochlear Americas	Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit	07/27/2022
K190589	Cochlear Americas	Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments	07/03/2019
K191921	Cochlear Americas	Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments	11/15/2019
K201983	Med-El Elektromedizinische Geraete GmbH	BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)	10/09/2020
DEN170009	MED-EL Elektromedizinische Geraete GmbH	Bonebridge	07/20/2018
K183373	MED-EL Elektromedizinische Geraete GmbH	Bonebridge	03/07/2019
K191457	MED-EL Elektromedizinische Geraete GmbH	BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)	09/18/2019
K200504	MED-EL Elektromedizinische Geraete GmbH	BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote	07/29/2020