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FDA 510(k)

BELTONE COMPARAFIT

K-Number: K946340 · 1995-04-13

ApplicantBeltone Electronics Corp.
Decision Date1995-04-13
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BELTONE COMPARAFIT 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 1995-04-13 under 510(k) number K946340. 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 COMPARAFIT?

BELTONE COMPARAFIT is a medical device that received FDA 510(k) clearance on 1995-04-13. The listed applicant is Beltone Electronics Corp.. The 510(k) number is K946340.

When did BELTONE COMPARAFIT receive FDA 510(k) clearance?

BELTONE COMPARAFIT received FDA 510(k) clearance on 1995-04-13, under 510(k) number K946340.

Who is the listed applicant for BELTONE COMPARAFIT?

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 COMPARAFIT?

The FDA product code for BELTONE COMPARAFIT is ESD.

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Other records listing Beltone Electronics 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.

K971852AIR CONDUCTION HAEARING AIDSK963958IMPRESS, PERFECTA, ACU-FORM, AND ACUFITK955930BELTONE COMPOSER 2000 BTE HPK954936BELTONE ULTIMA 80 OTOSONIC POWER PASK943616BELTONE PERSONAL HEARING SCREENERK951587BELTONE PETITE PLUS BELTONE PETITE PLUS CLEARVIOCE K

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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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