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FDA 510(k)

SIMPLYGO PORTABLE OXYGEN CONCENTRATOR

K-Number: K111885 · 2011-11-04

ApplicantRespironics, Inc.
Decision Date2011-11-04
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SIMPLYGO PORTABLE OXYGEN CONCENTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2011-11-04 under 510(k) number K111885. 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 SIMPLYGO PORTABLE OXYGEN CONCENTRATOR?

SIMPLYGO PORTABLE OXYGEN CONCENTRATOR is a medical device that received FDA 510(k) clearance on 2011-11-04. The listed applicant is Respironics, Inc.. The 510(k) number is K111885.

When did SIMPLYGO PORTABLE OXYGEN CONCENTRATOR receive FDA 510(k) clearance?

SIMPLYGO PORTABLE OXYGEN CONCENTRATOR received FDA 510(k) clearance on 2011-11-04, under 510(k) number K111885.

Who is the listed applicant for SIMPLYGO PORTABLE OXYGEN CONCENTRATOR?

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

What is the FDA product code for SIMPLYGO PORTABLE OXYGEN CONCENTRATOR?

The FDA product code for SIMPLYGO PORTABLE OXYGEN CONCENTRATOR is CAW.

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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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