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FDA 510(k)

ITC HEARING AID CLUB MODEL LM40

K-Number: K923295 · 1992-09-23

Decision Date1992-09-23
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ITC HEARING AID CLUB MODEL LM40 is the device name listed in this FDA 510(k) record. The listed applicant is Club Hearing Instruments A/S. It received FDA 510(k) clearance on 1992-09-23 under 510(k) number K923295. 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 ITC HEARING AID CLUB MODEL LM40?

ITC HEARING AID CLUB MODEL LM40 is a medical device that received FDA 510(k) clearance on 1992-09-23. The listed applicant is Club Hearing Instruments A/S. The 510(k) number is K923295.

When did ITC HEARING AID CLUB MODEL LM40 receive FDA 510(k) clearance?

ITC HEARING AID CLUB MODEL LM40 received FDA 510(k) clearance on 1992-09-23, under 510(k) number K923295.

Who is the listed applicant for ITC HEARING AID CLUB MODEL LM40?

The FDA 510(k) record lists Club Hearing Instruments A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ITC HEARING AID CLUB MODEL LM40?

The FDA product code for ITC HEARING AID CLUB MODEL LM40 is ESD.

Related Clinical Trials

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.

Other records listing Club Hearing Instruments A/S 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.

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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