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FDA 510(k)

AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON

K-Number: K121793 · 2012-11-01

ApplicantAudifon-USA, Inc.
Decision Date2012-11-01
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON is the device name listed in this FDA 510(k) record. The listed applicant is Audifon-USA, Inc.. It received FDA 510(k) clearance on 2012-11-01 under 510(k) number K121793. 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 AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON?

AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON is a medical device that received FDA 510(k) clearance on 2012-11-01. The listed applicant is Audifon-USA, Inc.. The 510(k) number is K121793.

When did AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON receive FDA 510(k) clearance?

AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON received FDA 510(k) clearance on 2012-11-01, under 510(k) number K121793.

Who is the listed applicant for AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON?

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

What is the FDA product code for AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON?

The FDA product code for AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON is LXB.

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Other records listing Audifon-USA, Inc. 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.

K130514AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRTK130417AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T SK083488JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT

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Official Source

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