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FDA 510(k)

TACTIL EAR

K-Number: K831501 · 1983-08-26

ApplicantEar Three Systems
Decision Date1983-08-26
Product CodeLRA
DecisionSubstantially Equivalent

Device Summary

TACTIL EAR is the device name listed in this FDA 510(k) record. The listed applicant is Ear Three Systems. It received FDA 510(k) clearance on 1983-08-26 under 510(k) number K831501. The device is classified under product code LRA. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TACTIL EAR?

TACTIL EAR is a medical device that received FDA 510(k) clearance on 1983-08-26. The listed applicant is Ear Three Systems. The 510(k) number is K831501.

When did TACTIL EAR receive FDA 510(k) clearance?

TACTIL EAR received FDA 510(k) clearance on 1983-08-26, under 510(k) number K831501.

Who is the listed applicant for TACTIL EAR?

The FDA 510(k) record lists Ear Three Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TACTIL EAR?

The FDA product code for TACTIL EAR is LRA.

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Related Devices (Code: LRA)

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.

K883853ETASevrain-Tech, Inc.K862471WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODERInstitute of LogopedicsK851441TACTICON 1600MedeconK851655TEACHER TMMonargue Intl.K843433KANIEVSKI SENSORY AID OR DEVICESpectro Industries, Inc.K830418TACTAIDAudiological Engineering Corp.

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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