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FDA 510(k)

TINNITUS MASKERS, MODELS S564&S574

K-Number: K771769 · 1978-01-03

ApplicantVicon Instrument Co.
Decision Date1978-01-03
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TINNITUS MASKERS, MODELS S564&S574 is the device name listed in this FDA 510(k) record. The listed applicant is Vicon Instrument Co.. It received FDA 510(k) clearance on 1978-01-03 under 510(k) number K771769. The device is classified under product code KLW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TINNITUS MASKERS, MODELS S564&S574?

TINNITUS MASKERS, MODELS S564&S574 is a medical device that received FDA 510(k) clearance on 1978-01-03. The listed applicant is Vicon Instrument Co.. The 510(k) number is K771769.

When did TINNITUS MASKERS, MODELS S564&S574 receive FDA 510(k) clearance?

TINNITUS MASKERS, MODELS S564&S574 received FDA 510(k) clearance on 1978-01-03, under 510(k) number K771769.

Who is the listed applicant for TINNITUS MASKERS, MODELS S564&S574?

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

What is the FDA product code for TINNITUS MASKERS, MODELS S564&S574?

The FDA product code for TINNITUS MASKERS, MODELS S564&S574 is KLW.

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Other records listing Vicon Instrument Co. as applicant

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Related Devices (Code: KLW)

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.

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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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