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FDA 510(k)

Rugged Oxygen Generator (ROG) (RO01-00001)

K-Number: K240561 · 2024-12-06

ApplicantMolecular Products , Ltd.
Decision Date2024-12-06
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Rugged Oxygen Generator (ROG) (RO01-00001) is a medical device manufactured by Molecular Products , Ltd.. It received FDA 510(k) clearance on 2024-12-06 under approval number K240561. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rugged Oxygen Generator (ROG) (RO01-00001)?

Rugged Oxygen Generator (ROG) (RO01-00001) is a medical device that received FDA 510(k) clearance on 2024-12-06. It is manufactured by Molecular Products , Ltd.. The 510(k) number is K240561.

When was Rugged Oxygen Generator (ROG) (RO01-00001) approved by the FDA?

Rugged Oxygen Generator (ROG) (RO01-00001) received FDA 510(k) clearance on 2024-12-06, under approval number K240561.

What company makes Rugged Oxygen Generator (ROG) (RO01-00001)?

Rugged Oxygen Generator (ROG) (RO01-00001) is manufactured by Molecular Products , Ltd..

What is the FDA product code for Rugged Oxygen Generator (ROG) (RO01-00001)?

The FDA product code for Rugged Oxygen Generator (ROG) (RO01-00001) is CAW.

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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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