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FDA 510(k)

TEACHER TM

K-Number: K851655 · 1985-06-20

ApplicantMonargue Intl.
Decision Date1985-06-20
Product CodeLRA
DecisionSubstantially Equivalent

Device Summary

TEACHER TM is the device name listed in this FDA 510(k) record. The listed applicant is Monargue Intl.. It received FDA 510(k) clearance on 1985-06-20 under 510(k) number K851655. The device is classified under product code LRA. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEACHER TM?

TEACHER TM is a medical device that received FDA 510(k) clearance on 1985-06-20. The listed applicant is Monargue Intl.. The 510(k) number is K851655.

When did TEACHER TM receive FDA 510(k) clearance?

TEACHER TM received FDA 510(k) clearance on 1985-06-20, under 510(k) number K851655.

Who is the listed applicant for TEACHER TM?

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

What is the FDA product code for TEACHER TM?

The FDA product code for TEACHER TM 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 1600MedeconK843433KANIEVSKI SENSORY AID OR DEVICESpectro Industries, Inc.K831501TACTIL EAREar Three SystemsK830418TACTAIDAudiological 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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