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FDA 510(k)

Endoscopy Oxygen Mask

K-Number: K220533 · 2022-11-16

ApplicantEngineered Medical Systems, Inc.
Decision Date2022-11-16
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Endoscopy Oxygen Mask is a medical device manufactured by Engineered Medical Systems, Inc.. It received FDA 510(k) clearance on 2022-11-16 under approval number K220533. 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 Endoscopy Oxygen Mask?

Endoscopy Oxygen Mask is a medical device that received FDA 510(k) clearance on 2022-11-16. It is manufactured by Engineered Medical Systems, Inc.. The 510(k) number is K220533.

When was Endoscopy Oxygen Mask approved by the FDA?

Endoscopy Oxygen Mask received FDA 510(k) clearance on 2022-11-16, under approval number K220533.

What company makes Endoscopy Oxygen Mask?

Endoscopy Oxygen Mask is manufactured by Engineered Medical Systems, Inc..

What is the FDA product code for Endoscopy Oxygen Mask?

The FDA product code for Endoscopy Oxygen Mask is CCK.

Related Clinical Trials

NCT07234188 POM vs HFNC for Hypoxemia Prevention in Children COMPLETED NCT07500779 Impact of Nasal Mask Versus Nasal Cannula Oxygenation on Hypoxemia in Gastrointestinal Endoscopy: A Brain Function Monitoring (SedLine)-Guided Randomized Controlled Trial (NAMSHIC) COMPLETED NCT07489157 Real-Time End-Tidal Carbon Dioxide Monitoring for Early Warning of Hypoxemia in Painless Gastrointestinal Endoscopy NOT_YET_RECRUITING

Related Devices (Code: CCK)

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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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