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FDA 510(k)

SIMEOX 200 Airway Clearance Device

K-Number: K241091 · 2024-12-23

ApplicantInogen, Inc.
Decision Date2024-12-23
Product CodeSDT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SIMEOX 200 Airway Clearance Device is a medical device manufactured by Inogen, Inc.. It received FDA 510(k) clearance on 2024-12-23 under approval number K241091. The device is classified under product code SDT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMEOX 200 Airway Clearance Device?

SIMEOX 200 Airway Clearance Device is a medical device that received FDA 510(k) clearance on 2024-12-23. It is manufactured by Inogen, Inc.. The 510(k) number is K241091.

When was SIMEOX 200 Airway Clearance Device approved by the FDA?

SIMEOX 200 Airway Clearance Device received FDA 510(k) clearance on 2024-12-23, under approval number K241091.

What company makes SIMEOX 200 Airway Clearance Device?

SIMEOX 200 Airway Clearance Device is manufactured by Inogen, Inc..

What is the FDA product code for SIMEOX 200 Airway Clearance Device?

The FDA product code for SIMEOX 200 Airway Clearance Device is SDT.

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Other Devices by Inogen, Inc.

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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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