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FDA 510(k)

NUVOX BEDSIDE TINNITUS MASKER

K-Number: K802750 · 1980-12-31

ApplicantHal-Hen Co., Inc.
Decision Date1980-12-31
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NUVOX BEDSIDE TINNITUS MASKER is the device name listed in this FDA 510(k) record. The listed applicant is Hal-Hen Co., Inc.. It received FDA 510(k) clearance on 1980-12-31 under 510(k) number K802750. 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 NUVOX BEDSIDE TINNITUS MASKER?

NUVOX BEDSIDE TINNITUS MASKER is a medical device that received FDA 510(k) clearance on 1980-12-31. The listed applicant is Hal-Hen Co., Inc.. The 510(k) number is K802750.

When did NUVOX BEDSIDE TINNITUS MASKER receive FDA 510(k) clearance?

NUVOX BEDSIDE TINNITUS MASKER received FDA 510(k) clearance on 1980-12-31, under 510(k) number K802750.

Who is the listed applicant for NUVOX BEDSIDE TINNITUS MASKER?

The FDA 510(k) record lists Hal-Hen Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NUVOX BEDSIDE TINNITUS MASKER?

The FDA product code for NUVOX BEDSIDE TINNITUS MASKER is KLW.

Related Clinical Trials

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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Other records listing Hal-Hen Co., Inc. as applicant

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.

K780738PENTAX ST-1A

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.

K260413Levo Gen 2 Tinnitus Therapy SystemLevo Medical CorporationK260614Tinnitus TherapySivantos GmbHK233435Peace N Quiet (0.7.0)Pnq HealthK223694Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)Duearity ABK221168Tinnitogram Signal GeneratorGoldenear Company, Inc.K221125SilentCloudAureliym GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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