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FDA 510(k)

SLEEPAPP

K-Number: K182202 · 2019-01-11

ApplicantComfort Acrylics, Inc.
Decision Date2019-01-11
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SLEEPAPP is the device name listed in this FDA 510(k) record. The listed applicant is Comfort Acrylics, Inc.. It received FDA 510(k) clearance on 2019-01-11 under 510(k) number K182202. 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 SLEEPAPP?

SLEEPAPP is a medical device that received FDA 510(k) clearance on 2019-01-11. The listed applicant is Comfort Acrylics, Inc.. The 510(k) number is K182202.

When did SLEEPAPP receive FDA 510(k) clearance?

SLEEPAPP received FDA 510(k) clearance on 2019-01-11, under 510(k) number K182202.

Who is the listed applicant for SLEEPAPP?

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

What is the FDA product code for SLEEPAPP?

The FDA product code for SLEEPAPP is LRK.

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.

K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLCK253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte. , Ltd.

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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