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FDA 510(k)

OTICON E28A

K-Number: K841436 · 1984-06-27

ApplicantOticon Corp.
Decision Date1984-06-27
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OTICON E28A is the device name listed in this FDA 510(k) record. The listed applicant is Oticon Corp.. It received FDA 510(k) clearance on 1984-06-27 under 510(k) number K841436. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTICON E28A?

OTICON E28A is a medical device that received FDA 510(k) clearance on 1984-06-27. The listed applicant is Oticon Corp.. The 510(k) number is K841436.

When did OTICON E28A receive FDA 510(k) clearance?

OTICON E28A received FDA 510(k) clearance on 1984-06-27, under 510(k) number K841436.

Who is the listed applicant for OTICON E28A?

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

What is the FDA product code for OTICON E28A?

The FDA product code for OTICON E28A is ESD.

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Other records listing Oticon Corp. 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.

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Related Devices (Code: ESD)

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.

K232999Lyric4 Hearing AidSonova AGK130790LYRIC2Phonak, LLCK081136LYRIC HEARING AIDInsound Medical, Inc.K021867INSOUND XT SERIES HEARING AIDInsound Medical, Inc.K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)Siemens Hearing Instruments, Inc.K984518SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELLSonic Innovations, Inc.

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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