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FDA 510(k)

REXTON HS(HEARING SYSTEM)

K-Number: K791548 · 1979-09-28

ApplicantArgosy Intl. (Usa), Inc.
Decision Date1979-09-28
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REXTON HS(HEARING SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Argosy Intl. (Usa), Inc.. It received FDA 510(k) clearance on 1979-09-28 under 510(k) number K791548. The device is classified under product code HSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REXTON HS(HEARING SYSTEM)?

REXTON HS(HEARING SYSTEM) is a medical device that received FDA 510(k) clearance on 1979-09-28. The listed applicant is Argosy Intl. (Usa), Inc.. The 510(k) number is K791548.

When did REXTON HS(HEARING SYSTEM) receive FDA 510(k) clearance?

REXTON HS(HEARING SYSTEM) received FDA 510(k) clearance on 1979-09-28, under 510(k) number K791548.

Who is the listed applicant for REXTON HS(HEARING SYSTEM)?

The FDA 510(k) record lists Argosy Intl. (Usa), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REXTON HS(HEARING SYSTEM)?

The FDA product code for REXTON HS(HEARING SYSTEM) is HSD.

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Other records listing Argosy Intl. (Usa), 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.

K823075REXTONK781095HEARING AID, BEHIND THE EARK781094HEARING AID, EYEGLASSK781096HEARING AID, EYEGLASS, B-12K780919M25 PP (BEHIND THE EAR)K780921MM-CE DM (BEHIND THE EAR)

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Related Devices (Code: HSD)

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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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