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FDA 510(k)

PureSleep (OTC use)

K-Number: K190058 · 2019-04-11

ApplicantSleep Science Partners, Inc.
Decision Date2019-04-11
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PureSleep (OTC use) 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 2019-04-11 under 510(k) number K190058. 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 (OTC use)?

PureSleep (OTC use) is a medical device that received FDA 510(k) clearance on 2019-04-11. The listed applicant is Sleep Science Partners, Inc.. The 510(k) number is K190058.

When did PureSleep (OTC use) receive FDA 510(k) clearance?

PureSleep (OTC use) received FDA 510(k) clearance on 2019-04-11, under 510(k) number K190058.

Who is the listed applicant for PureSleep (OTC use)?

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 (OTC use)?

The FDA product code for PureSleep (OTC use) 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.

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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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