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FDA 510(k)

PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF)

K-Number: K051887 · 2005-09-27

ApplicantCarleton Life Support Systems, Inc.
Decision Date2005-09-27
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF) 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 2005-09-27 under 510(k) number K051887. 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 PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF)?

PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF) is a medical device that received FDA 510(k) clearance on 2005-09-27. The listed applicant is Carleton Life Support Systems, Inc.. The 510(k) number is K051887.

When did PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF) receive FDA 510(k) clearance?

PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF) received FDA 510(k) clearance on 2005-09-27, under 510(k) number K051887.

Who is the listed applicant for PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF)?

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 PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF)?

The FDA product code for PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF) is CAW.

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.

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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.

K082829AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS)K071904DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M)

Related Devices (Code: CAW)

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.

K254289Portable Oxygen Concentrator (OX-1A-E, OX-1B)Oxytek Medical Technology Co., Ltd.K260171Portable Oxygen Concentrator (PO1 5B, PO1 6B)BMC Medical Co., Ltd.K252399Portable Oxygen ConcentratorHonsun (Nantong) Co., Ltd.K252965Oxygen Concentrator (OX-5A, OX-5C)Oxytek Medical Technology Co., Ltd.K252407OxyGo Portable Oxygen Concentrator (1400-7000)Mv Life, LLCK253549DeVilbiss 5 Liter Oxygen Concentrator (555)Devilbiss Healthcare, LLC

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.

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