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FDA 510(k)

COCHLEAR BAHA IMPLANT SYSTEM

K-Number: K121317 · 2012-10-12

ApplicantCochlear Americas
Decision Date2012-10-12
Product CodeMAH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

COCHLEAR BAHA IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cochlear Americas. It received FDA 510(k) clearance on 2012-10-12 under 510(k) number K121317. The device is classified under product code MAH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COCHLEAR BAHA IMPLANT SYSTEM?

COCHLEAR BAHA IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2012-10-12. The listed applicant is Cochlear Americas. The 510(k) number is K121317.

When did COCHLEAR BAHA IMPLANT SYSTEM receive FDA 510(k) clearance?

COCHLEAR BAHA IMPLANT SYSTEM received FDA 510(k) clearance on 2012-10-12, under 510(k) number K121317.

Who is the listed applicant for COCHLEAR BAHA IMPLANT SYSTEM?

The FDA 510(k) record lists Cochlear Americas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COCHLEAR BAHA IMPLANT SYSTEM?

The FDA product code for COCHLEAR BAHA IMPLANT SYSTEM is MAH.

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Other records listing Cochlear Americas as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260902Cochlear™ 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® SystemK240155Cochlear Osia SystemK231604Instrument CaseK220922Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI KitK212136Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart AppK202048Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App

View all 18 devices →

Related Devices (Code: MAH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261142Ponto 5 Mini; Ponto 5 SuperpowerOticon Medical ABK203807Ponto Bone Anchored Hearing System, MONO Surgery KitOticon Medical ABK182116BA310 Abutment, BIA310 Implant/AbutmentCochlear AmericasK152820Ponto Bone Anchored Hearing SystemOticon Medical ABK121228PONTO BONE ANCHORED HEARING SYSTEMOticon Medical ABK112053OBC BONE ANCHORED HEARING SYSTEMOticon Medical AB

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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