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FDA 510(k)

BELTONE OPERA/OPERA MHP/OPERA MAX

K-Number: K940102 · 1994-04-01

ApplicantBeltone Electronics Corp.
Decision Date1994-04-01
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BELTONE OPERA/OPERA MHP/OPERA MAX is the device name listed in this FDA 510(k) record. The listed applicant is Beltone Electronics Corp.. It received FDA 510(k) clearance on 1994-04-01 under 510(k) number K940102. 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 BELTONE OPERA/OPERA MHP/OPERA MAX?

BELTONE OPERA/OPERA MHP/OPERA MAX is a medical device that received FDA 510(k) clearance on 1994-04-01. The listed applicant is Beltone Electronics Corp.. The 510(k) number is K940102.

When did BELTONE OPERA/OPERA MHP/OPERA MAX receive FDA 510(k) clearance?

BELTONE OPERA/OPERA MHP/OPERA MAX received FDA 510(k) clearance on 1994-04-01, under 510(k) number K940102.

Who is the listed applicant for BELTONE OPERA/OPERA MHP/OPERA MAX?

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

What is the FDA product code for BELTONE OPERA/OPERA MHP/OPERA MAX?

The FDA product code for BELTONE OPERA/OPERA MHP/OPERA MAX is ESD.

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Other records listing Beltone Electronics Corp. as applicant

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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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