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FDA 510(k)

Meridian PM

K-Number: K170053 · 2017-11-28

Decision Date2017-11-28
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Meridian PM is a medical device manufactured by The Center For Craniofacial & Dental Sleep Medicine. It received FDA 510(k) clearance on 2017-11-28 under approval 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. It is manufactured by The Center For Craniofacial & Dental Sleep Medicine. The 510(k) number is K170053.

When was Meridian PM approved by the FDA?

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

What company makes Meridian PM?

Meridian PM is manufactured by The Center For Craniofacial & Dental Sleep Medicine.

What is the FDA product code for Meridian PM?

The FDA product code for Meridian PM is LRK.

Related Devices (Code: LRK)

Official Source

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