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FDA 510(k)

THE EQUALIZER AIRWAY DEVICE

K-Number: K870501 · 1987-03-04

ApplicantSleep Renewal, Inc.
Decision Date1987-03-04
Product CodeLQZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THE EQUALIZER AIRWAY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Sleep Renewal, Inc.. It received FDA 510(k) clearance on 1987-03-04 under 510(k) number K870501. The device is classified under product code LQZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE EQUALIZER AIRWAY DEVICE?

THE EQUALIZER AIRWAY DEVICE is a medical device that received FDA 510(k) clearance on 1987-03-04. The listed applicant is Sleep Renewal, Inc.. The 510(k) number is K870501.

When did THE EQUALIZER AIRWAY DEVICE receive FDA 510(k) clearance?

THE EQUALIZER AIRWAY DEVICE received FDA 510(k) clearance on 1987-03-04, under 510(k) number K870501.

Who is the listed applicant for THE EQUALIZER AIRWAY DEVICE?

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

What is the FDA product code for THE EQUALIZER AIRWAY DEVICE?

The FDA product code for THE EQUALIZER AIRWAY DEVICE is LQZ.

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Related Devices (Code: LQZ)

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.

K233754AIO BreatheAiomega, LLCK230532RADx Intraoral Appliance for Snoring and Sleep ApneaAchaemenid, LLCK203712The SlideBiotex, Inc.K191320Slow Wave DS8Slow Wave, Inc.K192581The NightBlocks ApplianceAdvanced Facialdontics, LLCK162816SML-OSA2 AppliancesSelane Products, Inc.

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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