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FDA 510(k)

MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS

K-Number: K014301 · 2002-02-11

ApplicantMerits Health Products Co., Ltd.
Decision Date2002-02-11
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Merits Health Products Co., Ltd.. It received FDA 510(k) clearance on 2002-02-11 under 510(k) number K014301. 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 MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS?

MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS is a medical device that received FDA 510(k) clearance on 2002-02-11. The listed applicant is Merits Health Products Co., Ltd.. The 510(k) number is K014301.

When did MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS receive FDA 510(k) clearance?

MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS received FDA 510(k) clearance on 2002-02-11, under 510(k) number K014301.

Who is the listed applicant for MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS?

The FDA 510(k) record lists Merits Health Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS?

The FDA product code for MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS 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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