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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 the device name listed in this FDA 510(k) record. The listed applicant is Medipines Corporation. It received FDA 510(k) clearance on 2019-01-11 under 510(k) 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. The listed applicant is Medipines Corporation. The 510(k) number is K180902.

When did MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly receive FDA 510(k) clearance?

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

Who is the listed applicant for MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly?

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

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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