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FDA 510(k)

GOLD L MODULE, ITE

K-Number: K933039 · 1993-08-02

ApplicantElectone, Inc.
Decision Date1993-08-02
Product CodeLRB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GOLD L MODULE, ITE is the device name listed in this FDA 510(k) record. The listed applicant is Electone, Inc.. It received FDA 510(k) clearance on 1993-08-02 under 510(k) number K933039. The device is classified under product code LRB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOLD L MODULE, ITE?

GOLD L MODULE, ITE is a medical device that received FDA 510(k) clearance on 1993-08-02. The listed applicant is Electone, Inc.. The 510(k) number is K933039.

When did GOLD L MODULE, ITE receive FDA 510(k) clearance?

GOLD L MODULE, ITE received FDA 510(k) clearance on 1993-08-02, under 510(k) number K933039.

Who is the listed applicant for GOLD L MODULE, ITE?

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

What is the FDA product code for GOLD L MODULE, ITE?

The FDA product code for GOLD L MODULE, ITE is LRB.

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.

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Other records listing Electone, 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.

K973266Z DEQ-IIK961084AM 400K955702SONATA U-01K953050Z33K953047Z20K953051Z35

View all 73 devices →

Related Devices (Code: LRB)

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.

K974219FACEPLATE ASSEMBLYFinetone Hearing InstrumentsK961593INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDSSegi Hearing Aid Co.K942722MODULE PROGRAMElectone, Inc.K942236AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)Audina Hearing InstrumentK935048ARTISAN PROGRAMMER & HEARING AIDTelex Communications, Inc.K933046SILVER L MODULE, ITEElectone, Inc.

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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