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FDA 510(k)

DUALINE 100 BTE

K-Number: K973948 · 1997-10-28

ApplicantBernafon-Maico, Inc.
Decision Date1997-10-28
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DUALINE 100 BTE is the device name listed in this FDA 510(k) record. The listed applicant is Bernafon-Maico, Inc.. It received FDA 510(k) clearance on 1997-10-28 under 510(k) number K973948. 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 DUALINE 100 BTE?

DUALINE 100 BTE is a medical device that received FDA 510(k) clearance on 1997-10-28. The listed applicant is Bernafon-Maico, Inc.. The 510(k) number is K973948.

When did DUALINE 100 BTE receive FDA 510(k) clearance?

DUALINE 100 BTE received FDA 510(k) clearance on 1997-10-28, under 510(k) number K973948.

Who is the listed applicant for DUALINE 100 BTE?

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

What is the FDA product code for DUALINE 100 BTE?

The FDA product code for DUALINE 100 BTE is ESD.

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Other records listing Bernafon-Maico, 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.

K982723MAICO MA42K981142MAICO MA53K974211OPUS 2 - FULL CONCHA SERIES - ITEK974069OPUS 2 - CANAL SERIES (ITC)K974152OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)K971158DUALINE 400 CIC

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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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