Device Listing 1501299603

Listing Summary#

Listing key: 1501299603
Premarket submission: K260902
Device: Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Processor;Cochlear™ Osia® 3 Charger;Cochlear™ Osia® 3 Aqua+;Cochlear™ Osia® Fitting Software 3;Cochlear™ Osia® Smart App;Cochlear™ Osia® System
Applicant: Cochlear Americas
Product code: PFO
Decision date: 2026-07-10

Registration key, Registration, FEI table
Registration key	Registration	FEI	Company	Status	Initial importer	Expiration	Address
24334	9616024	3003222064	COCHLEAR BONE ANCHORED SOLUTIONS AB	1	N	2026-01-01	Konstruktionsvagen 14 Molnlycke Vastra Gotaland SE SE-435 33
24330	3005900820	3005900820	COCHLEAR AMERICAS	1	N	2026-01-01	10350 Park Meadows Drive Lone Tree CO US 80124
154082	3009092818	3009092818	Cochlear Ltd	1	N	2026-01-01	1 University Ave Macquarie University New South Wales AU 2109
201311	3013177549	3013177549	Laura Blair	1	N	2026-01-01	10350 Park Meadows Drive Lone Tree CO US 80124
221054	3014579188	3014579188	Cochlear Americas Warehouse	1	Y	2026-01-01	7101 S. Fulton St. Suite E Centennial CO US 80112