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FDA 510(k)

TACTICON 1600

K-Number: K851441 · 1985-06-27

ApplicantMedecon
Decision Date1985-06-27
Product CodeLRA
DecisionSubstantially Equivalent

Device Summary

TACTICON 1600 is the device name listed in this FDA 510(k) record. The listed applicant is Medecon. It received FDA 510(k) clearance on 1985-06-27 under 510(k) number K851441. The device is classified under product code LRA. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TACTICON 1600?

TACTICON 1600 is a medical device that received FDA 510(k) clearance on 1985-06-27. The listed applicant is Medecon. The 510(k) number is K851441.

When did TACTICON 1600 receive FDA 510(k) clearance?

TACTICON 1600 received FDA 510(k) clearance on 1985-06-27, under 510(k) number K851441.

Who is the listed applicant for TACTICON 1600?

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

What is the FDA product code for TACTICON 1600?

The FDA product code for TACTICON 1600 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 LogopedicsK851655TEACHER TMMonargue Intl.K843433KANIEVSKI 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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