FDA 510(k)

REXTON

K-Number: K823075 · 1982-11-08

Decision Date1982-11-08

Product Code

DecisionSubstantially Equivalent

Device Summary

REXTON 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 1982-11-08 under 510(k) number K823075. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REXTON?

REXTON is a medical device that received FDA 510(k) clearance on 1982-11-08. The listed applicant is Argosy Intl. (Usa), Inc.. The 510(k) number is K823075.

When did REXTON receive FDA 510(k) clearance?

REXTON received FDA 510(k) clearance on 1982-11-08, under 510(k) number K823075.

Who is the listed applicant for REXTON?

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

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Other records listing Argosy Intl. (Usa), Inc. as applicant

K791548REXTON HS(HEARING SYSTEM)K781095HEARING AID, BEHIND THE EAR K781094HEARING AID, EYEGLASS K781096HEARING AID, EYEGLASS, B-12 K780919M25 PP (BEHIND THE EAR)K780921MM-CE DM (BEHIND THE EAR)

View all 14 devices →

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.