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FDA 510(k)

BELTONE OPERA CLEARVOICE IC, ITC (IN THE CANAL)

K-Number: K922301 · 1992-06-10

ApplicantBeltone Electronics Corp.
Decision Date1992-06-10
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BELTONE OPERA CLEARVOICE IC, ITC (IN THE CANAL) 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 1992-06-10 under 510(k) number K922301. 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 CLEARVOICE IC, ITC (IN THE CANAL)?

BELTONE OPERA CLEARVOICE IC, ITC (IN THE CANAL) is a medical device that received FDA 510(k) clearance on 1992-06-10. The listed applicant is Beltone Electronics Corp.. The 510(k) number is K922301.

When did BELTONE OPERA CLEARVOICE IC, ITC (IN THE CANAL) receive FDA 510(k) clearance?

BELTONE OPERA CLEARVOICE IC, ITC (IN THE CANAL) received FDA 510(k) clearance on 1992-06-10, under 510(k) number K922301.

Who is the listed applicant for BELTONE OPERA CLEARVOICE IC, ITC (IN THE CANAL)?

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 CLEARVOICE IC, ITC (IN THE CANAL)?

The FDA product code for BELTONE OPERA CLEARVOICE IC, ITC (IN THE CANAL) 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.

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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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