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FDA 510(k)

PURESLEEP

K-Number: K113022 · 2012-06-11

ApplicantSleep Science Partners, Inc.
Decision Date2012-06-11
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PURESLEEP is the device name listed in this FDA 510(k) record. The listed applicant is Sleep Science Partners, Inc.. It received FDA 510(k) clearance on 2012-06-11 under 510(k) number K113022. 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 PURESLEEP?

PURESLEEP is a medical device that received FDA 510(k) clearance on 2012-06-11. The listed applicant is Sleep Science Partners, Inc.. The 510(k) number is K113022.

When did PURESLEEP receive FDA 510(k) clearance?

PURESLEEP received FDA 510(k) clearance on 2012-06-11, under 510(k) number K113022.

Who is the listed applicant for PURESLEEP?

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

What is the FDA product code for PURESLEEP?

The FDA product code for PURESLEEP is LRK.

Related Clinical Trials

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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Other records listing Sleep Science Partners, Inc. 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.

K190058PureSleep (OTC use)

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.

K262104Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)Ram.Shaw Pte., Ltd.K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLC

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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