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FDA 510(k)

MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly

K-Number: K180902 · 2019-01-11

ApplicantMedipines Corporation
Decision Date2019-01-11
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly is a medical device manufactured by Medipines Corporation. It received FDA 510(k) clearance on 2019-01-11 under approval number K180902. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly?

MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly is a medical device that received FDA 510(k) clearance on 2019-01-11. It is manufactured by Medipines Corporation. The 510(k) number is K180902.

When was MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly approved by the FDA?

MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly received FDA 510(k) clearance on 2019-01-11, under approval number K180902.

What company makes MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly?

MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly is manufactured by Medipines Corporation.

What is the FDA product code for MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly?

The FDA product code for MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly is CCK.

Related Clinical Trials

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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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