FDA 510(k)

Panoramic Oxygen Mask (POM)

K-Number: K172365 · 2018-04-19

Decision Date2018-04-19

Product CodeCCK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Panoramic Oxygen Mask (POM) is a medical device manufactured by Pom Medical, LLC. It received FDA 510(k) clearance on 2018-04-19 under approval number K172365. 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 Panoramic Oxygen Mask (POM)?

Panoramic Oxygen Mask (POM) is a medical device that received FDA 510(k) clearance on 2018-04-19. It is manufactured by Pom Medical, LLC. The 510(k) number is K172365.

When was Panoramic Oxygen Mask (POM) approved by the FDA?

Panoramic Oxygen Mask (POM) received FDA 510(k) clearance on 2018-04-19, under approval number K172365.

What company makes Panoramic Oxygen Mask (POM)?

Panoramic Oxygen Mask (POM) is manufactured by Pom Medical, LLC.

What is the FDA product code for Panoramic Oxygen Mask (POM)?

The FDA product code for Panoramic Oxygen Mask (POM) is CCK.

Related Devices (Code: CCK)

K162343Westmed Gas Sampling Cannula with O2 deliveryWestmed, Inc. K151421Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample LinesSalter Labs K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtensionPhilips Medizin Systeme Boeblingen GmbH K171765Nihon Kohden CO2 MonitorNihon Kohden Corporation K171028CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessoriesGE Healthcare Finland Oy K161250OC-FLEX Flexible IntraOral CannulaVenture Therapeutics, Inc.

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.