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FDA 510(k)

OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)

K-Number: K974152 · 1997-12-15

ApplicantBernafon-Maico, Inc.
Decision Date1997-12-15
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) 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 1997-12-15 under 510(k) number K974152. 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 OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)?

OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) is a medical device that received FDA 510(k) clearance on 1997-12-15. The listed applicant is Bernafon-Maico, Inc.. The 510(k) number is K974152.

When did OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) receive FDA 510(k) clearance?

OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) received FDA 510(k) clearance on 1997-12-15, under 510(k) number K974152.

Who is the listed applicant for OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)?

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 OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)?

The FDA product code for OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) 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)K973948DUALINE 100 BTEK971158DUALINE 400 CIC

View all 9 devices →

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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