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FDA 510(k)

PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150

K-Number: K103563 · 2011-07-01

ApplicantPrecision Medical, Inc.
Decision Date2011-07-01
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150 is the device name listed in this FDA 510(k) record. The listed applicant is Precision Medical, Inc.. It received FDA 510(k) clearance on 2011-07-01 under 510(k) number K103563. 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 PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150?

PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150 is a medical device that received FDA 510(k) clearance on 2011-07-01. The listed applicant is Precision Medical, Inc.. The 510(k) number is K103563.

When did PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150 receive FDA 510(k) clearance?

PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150 received FDA 510(k) clearance on 2011-07-01, under 510(k) number K103563.

Who is the listed applicant for PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150?

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

What is the FDA product code for PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150?

The FDA product code for PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150 is CAW.

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Other records listing Precision Medical, 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.

K173807Accu O2 Oxygen AnalyzerK103324PRECISION LIQUID OXYGEN SYSTEMK090781HELIO2 BLENDERK072348PRECISION OXYGEN CONCENTRATORK063096PRECISION OXYGEN MONITORK053232PRECISION BLENDER

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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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