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FDA 510(k)

Respire Pink AT (Hard, Hard/Soft, EF)

K-Number: K192127 · 2020-02-05

ApplicantRespire Medical Holdings
Decision Date2020-02-05
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Respire Pink AT (Hard, Hard/Soft, EF) is the device name listed in this FDA 510(k) record. The listed applicant is Respire Medical Holdings. It received FDA 510(k) clearance on 2020-02-05 under 510(k) number K192127. 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 Respire Pink AT (Hard, Hard/Soft, EF)?

Respire Pink AT (Hard, Hard/Soft, EF) is a medical device that received FDA 510(k) clearance on 2020-02-05. The listed applicant is Respire Medical Holdings. The 510(k) number is K192127.

When did Respire Pink AT (Hard, Hard/Soft, EF) receive FDA 510(k) clearance?

Respire Pink AT (Hard, Hard/Soft, EF) received FDA 510(k) clearance on 2020-02-05, under 510(k) number K192127.

Who is the listed applicant for Respire Pink AT (Hard, Hard/Soft, EF)?

The FDA 510(k) record lists Respire Medical Holdings as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Respire Pink AT (Hard, Hard/Soft, EF)?

The FDA product code for Respire Pink AT (Hard, Hard/Soft, EF) 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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