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FDA 510(k)

BELTONE PERSONAL HEARING SCREENER

K-Number: K943616 · 1995-07-12

ApplicantBeltone Electronics Corp.
Decision Date1995-07-12
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BELTONE PERSONAL HEARING SCREENER 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 1995-07-12 under 510(k) number K943616. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BELTONE PERSONAL HEARING SCREENER?

BELTONE PERSONAL HEARING SCREENER is a medical device that received FDA 510(k) clearance on 1995-07-12. The listed applicant is Beltone Electronics Corp.. The 510(k) number is K943616.

When did BELTONE PERSONAL HEARING SCREENER receive FDA 510(k) clearance?

BELTONE PERSONAL HEARING SCREENER received FDA 510(k) clearance on 1995-07-12, under 510(k) number K943616.

Who is the listed applicant for BELTONE PERSONAL HEARING SCREENER?

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 PERSONAL HEARING SCREENER?

The FDA product code for BELTONE PERSONAL HEARING SCREENER is EWO.

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Other records listing Beltone Electronics Corp. as applicant

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Related Devices (Code: EWO)

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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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