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FDA 510(k)

Meridian PM

K-Number: K170053 · 2017-11-28

ApplicantThe Center For Craniofacial & Dental Sleep Medicine
Decision Date2017-11-28
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Meridian PM is the device name listed in this FDA 510(k) record. The listed applicant is The Center For Craniofacial & Dental Sleep Medicine. It received FDA 510(k) clearance on 2017-11-28 under 510(k) number K170053. 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 Meridian PM?

Meridian PM is a medical device that received FDA 510(k) clearance on 2017-11-28. The listed applicant is The Center For Craniofacial & Dental Sleep Medicine. The 510(k) number is K170053.

When did Meridian PM receive FDA 510(k) clearance?

Meridian PM received FDA 510(k) clearance on 2017-11-28, under 510(k) number K170053.

Who is the listed applicant for Meridian PM?

The FDA 510(k) record lists The Center For Craniofacial & Dental Sleep Medicine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Meridian PM?

The FDA product code for Meridian PM 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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