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FDA 510(k)

ORAL SLEEP DISORDER AID

K-Number: K991209 · 1999-09-22

ApplicantPerl-Rad Sleep Disorder Lab
Decision Date1999-09-22
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORAL SLEEP DISORDER AID is the device name listed in this FDA 510(k) record. The listed applicant is Perl-Rad Sleep Disorder Lab. It received FDA 510(k) clearance on 1999-09-22 under 510(k) number K991209. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORAL SLEEP DISORDER AID?

ORAL SLEEP DISORDER AID is a medical device that received FDA 510(k) clearance on 1999-09-22. The listed applicant is Perl-Rad Sleep Disorder Lab. The 510(k) number is K991209.

When did ORAL SLEEP DISORDER AID receive FDA 510(k) clearance?

ORAL SLEEP DISORDER AID received FDA 510(k) clearance on 1999-09-22, under 510(k) number K991209.

Who is the listed applicant for ORAL SLEEP DISORDER AID?

The FDA 510(k) record lists Perl-Rad Sleep Disorder Lab as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORAL SLEEP DISORDER AID?

The FDA product code for ORAL SLEEP DISORDER AID is LRK.

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Related Devices (Code: LRK)

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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