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FDA 510(k)

SOUND RELIEF

K-Number: K912659 · 1991-09-06

ApplicantWindmere Corp.
Decision Date1991-09-06
Product CodeIRO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SOUND RELIEF is the device name listed in this FDA 510(k) record. The listed applicant is Windmere Corp.. It received FDA 510(k) clearance on 1991-09-06 under 510(k) number K912659. The device is classified under product code IRO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOUND RELIEF?

SOUND RELIEF is a medical device that received FDA 510(k) clearance on 1991-09-06. The listed applicant is Windmere Corp.. The 510(k) number is K912659.

When did SOUND RELIEF receive FDA 510(k) clearance?

SOUND RELIEF received FDA 510(k) clearance on 1991-09-06, under 510(k) number K912659.

Who is the listed applicant for SOUND RELIEF?

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

What is the FDA product code for SOUND RELIEF?

The FDA product code for SOUND RELIEF is IRO.

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Other records listing Windmere Corp. 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.

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Related Devices (Code: IRO)

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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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