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FDA 510(k)

GOLD AF MODULE, ITE

K-Number: K933038 · 1993-08-02

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

Device Summary

GOLD AF 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 K933038. 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 AF MODULE, ITE?

GOLD AF 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 K933038.

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

GOLD AF MODULE, ITE received FDA 510(k) clearance on 1993-08-02, under 510(k) number K933038.

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

The FDA product code for GOLD AF 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.K933039GOLD 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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