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FDA 510(k)

ARTISAN PROGRAMMER & HEARING AID

K-Number: K935048 · 1994-02-09

ApplicantTelex Communications, Inc.
Decision Date1994-02-09
Product CodeLRB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ARTISAN PROGRAMMER & HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Telex Communications, Inc.. It received FDA 510(k) clearance on 1994-02-09 under 510(k) number K935048. 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 ARTISAN PROGRAMMER & HEARING AID?

ARTISAN PROGRAMMER & HEARING AID is a medical device that received FDA 510(k) clearance on 1994-02-09. The listed applicant is Telex Communications, Inc.. The 510(k) number is K935048.

When did ARTISAN PROGRAMMER & HEARING AID receive FDA 510(k) clearance?

ARTISAN PROGRAMMER & HEARING AID received FDA 510(k) clearance on 1994-02-09, under 510(k) number K935048.

Who is the listed applicant for ARTISAN PROGRAMMER & HEARING AID?

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

What is the FDA product code for ARTISAN PROGRAMMER & HEARING AID?

The FDA product code for ARTISAN PROGRAMMER & HEARING AID is LRB.

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Other records listing Telex Communications, 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.

K984243TELEX TINNITUS-COMPANIONK982683TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSIONK964639TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-IIK963915TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSIONK961143TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40K954579TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION

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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 InstrumentK933039GOLD L MODULE, ITEElectone, 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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