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FDA 510(k)

AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS)

K-Number: K082829 · 2008-12-22

ApplicantCarleton Life Support Systems, Inc.
Decision Date2008-12-22
Product CodeOLF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS) is the device name listed in this FDA 510(k) record. The listed applicant is Carleton Life Support Systems, Inc.. It received FDA 510(k) clearance on 2008-12-22 under 510(k) number K082829. The device is classified under product code OLF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS)?

AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS) is a medical device that received FDA 510(k) clearance on 2008-12-22. The listed applicant is Carleton Life Support Systems, Inc.. The 510(k) number is K082829.

When did AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS) receive FDA 510(k) clearance?

AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS) received FDA 510(k) clearance on 2008-12-22, under 510(k) number K082829.

Who is the listed applicant for AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS)?

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

What is the FDA product code for AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS)?

The FDA product code for AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS) is OLF.

Related Clinical Trials

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Other records listing Carleton Life Support Systems, Inc. as applicant

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.

K071904DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M)K051887PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF)

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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