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FDA 510(k)

VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV

K-Number: K880259 · 1989-04-03

ApplicantColorado Hearing Systems, Inc.
Decision Date1989-04-03
Product CodeLYN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV is the device name listed in this FDA 510(k) record. The listed applicant is Colorado Hearing Systems, Inc.. It received FDA 510(k) clearance on 1989-04-03 under 510(k) number K880259. The device is classified under product code LYN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV?

VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV is a medical device that received FDA 510(k) clearance on 1989-04-03. The listed applicant is Colorado Hearing Systems, Inc.. The 510(k) number is K880259.

When did VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV receive FDA 510(k) clearance?

VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV received FDA 510(k) clearance on 1989-04-03, under 510(k) number K880259.

Who is the listed applicant for VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV?

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

What is the FDA product code for VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV?

The FDA product code for VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV is LYN.

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Official Source

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