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FDA 510(k)

ASA ORAL APPLIANCES

K-Number: K130504 · 2013-10-18

ApplicantAmerican Sleep Association
Decision Date2013-10-18
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ASA ORAL APPLIANCES is the device name listed in this FDA 510(k) record. The listed applicant is American Sleep Association. It received FDA 510(k) clearance on 2013-10-18 under 510(k) number K130504. 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 ASA ORAL APPLIANCES?

ASA ORAL APPLIANCES is a medical device that received FDA 510(k) clearance on 2013-10-18. The listed applicant is American Sleep Association. The 510(k) number is K130504.

When did ASA ORAL APPLIANCES receive FDA 510(k) clearance?

ASA ORAL APPLIANCES received FDA 510(k) clearance on 2013-10-18, under 510(k) number K130504.

Who is the listed applicant for ASA ORAL APPLIANCES?

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

What is the FDA product code for ASA ORAL APPLIANCES?

The FDA product code for ASA ORAL APPLIANCES is LRK.

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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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