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FDA 510(k)

GAS TRANSFILL

K-Number: K091191 · 2009-10-23

ApplicantRespironics Inc., Sleep & Home Respiratory Group
Decision Date2009-10-23
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GAS TRANSFILL is the device name listed in this FDA 510(k) record. The listed applicant is Respironics Inc., Sleep & Home Respiratory Group. It received FDA 510(k) clearance on 2009-10-23 under 510(k) number K091191. 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 GAS TRANSFILL?

GAS TRANSFILL is a medical device that received FDA 510(k) clearance on 2009-10-23. The listed applicant is Respironics Inc., Sleep & Home Respiratory Group. The 510(k) number is K091191.

When did GAS TRANSFILL receive FDA 510(k) clearance?

GAS TRANSFILL received FDA 510(k) clearance on 2009-10-23, under 510(k) number K091191.

Who is the listed applicant for GAS TRANSFILL?

The FDA 510(k) record lists Respironics Inc., Sleep & Home Respiratory Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAS TRANSFILL?

The FDA product code for GAS TRANSFILL is CAW.

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Other records listing Respironics Inc., Sleep & Home Respiratory Group as applicant

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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

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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