FDA 510(k)

SIMEOX 200 Airway Clearance Device

K-Number: K241091 · 2024-12-23

Decision Date2024-12-23

Product CodeSDT

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SIMEOX 200 Airway Clearance Device is the device name listed in this FDA 510(k) record. The listed applicant is Inogen, Inc.. It received FDA 510(k) clearance on 2024-12-23 under 510(k) 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. The listed applicant is Inogen, Inc.. The 510(k) number is K241091.

When did SIMEOX 200 Airway Clearance Device receive FDA 510(k) clearance?

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

Who is the listed applicant for SIMEOX 200 Airway Clearance Device?

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

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06237348Simeox Therapy at Home Versus Standard of Care in NCFB Patients With CMHCOMPLETED NCT06487273Long-term Evaluation of the SIMEOX Device at Home in Non-cystic Fibrosis BronchiectasisRECRUITING

Other records listing Inogen, Inc. as applicant

K230052Inogen Rove 6 K222086Inogen Rove 4 Portable Oxygen Concentrator

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.