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FDA 510(k)

Respire Pink Series with DentiTrac

K-Number: K170692 · 2017-05-26

ApplicantRespire Medical Holding
Decision Date2017-05-26
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Respire Pink Series with DentiTrac is the device name listed in this FDA 510(k) record. The listed applicant is Respire Medical Holding. It received FDA 510(k) clearance on 2017-05-26 under 510(k) number K170692. 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 Series with DentiTrac?

Respire Pink Series with DentiTrac is a medical device that received FDA 510(k) clearance on 2017-05-26. The listed applicant is Respire Medical Holding. The 510(k) number is K170692.

When did Respire Pink Series with DentiTrac receive FDA 510(k) clearance?

Respire Pink Series with DentiTrac received FDA 510(k) clearance on 2017-05-26, under 510(k) number K170692.

Who is the listed applicant for Respire Pink Series with DentiTrac?

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

What is the FDA product code for Respire Pink Series with DentiTrac?

The FDA product code for Respire Pink Series with DentiTrac 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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