FDA 510(k)

XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO.

K-Number: K872168 · 1987-06-30

Decision Date1987-06-30

Product CodeLXB

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO. is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 1987-06-30 under 510(k) number K872168. 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 XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO.?

XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO. is a medical device that received FDA 510(k) clearance on 1987-06-30. The listed applicant is Xomed, Inc.. The 510(k) number is K872168.

When did XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO. receive FDA 510(k) clearance?

XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO. received FDA 510(k) clearance on 1987-06-30, under 510(k) number K872168.

Who is the listed applicant for XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO.?

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

What is the FDA product code for XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO.?

The FDA product code for XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO. is LXB.

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Other records listing Xomed, Inc. as applicant

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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.