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FDA 510(k)

COCHLEAR BAHA BP100

K-Number: K090720 · 2009-06-17

ApplicantCochlear Bone Anchored Systems AB
Decision Date2009-06-17
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

COCHLEAR BAHA BP100 is the device name listed in this FDA 510(k) record. The listed applicant is Cochlear Bone Anchored Systems AB. It received FDA 510(k) clearance on 2009-06-17 under 510(k) number K090720. The device is classified under product code LXB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COCHLEAR BAHA BP100?

COCHLEAR BAHA BP100 is a medical device that received FDA 510(k) clearance on 2009-06-17. The listed applicant is Cochlear Bone Anchored Systems AB. The 510(k) number is K090720.

When did COCHLEAR BAHA BP100 receive FDA 510(k) clearance?

COCHLEAR BAHA BP100 received FDA 510(k) clearance on 2009-06-17, under 510(k) number K090720.

Who is the listed applicant for COCHLEAR BAHA BP100?

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

What is the FDA product code for COCHLEAR BAHA BP100?

The FDA product code for COCHLEAR BAHA BP100 is LXB.

Related Clinical Trials

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.

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Other records listing Cochlear Bone Anchored Systems AB 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.

K080363BAHA CORDELLE II

Related Devices (Code: LXB)

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.

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Official Source

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

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