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FDA 510(k)

CARE ZY5BA OXYGEN CONCENTRATOR

K-Number: K102245 · 2010-11-09

ApplicantFoshan Care Medical Technology Co., Ltd.
Decision Date2010-11-09
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CARE ZY5BA OXYGEN CONCENTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Care Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2010-11-09 under 510(k) number K102245. 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 CARE ZY5BA OXYGEN CONCENTRATOR?

CARE ZY5BA OXYGEN CONCENTRATOR is a medical device that received FDA 510(k) clearance on 2010-11-09. The listed applicant is Foshan Care Medical Technology Co., Ltd.. The 510(k) number is K102245.

When did CARE ZY5BA OXYGEN CONCENTRATOR receive FDA 510(k) clearance?

CARE ZY5BA OXYGEN CONCENTRATOR received FDA 510(k) clearance on 2010-11-09, under 510(k) number K102245.

Who is the listed applicant for CARE ZY5BA OXYGEN CONCENTRATOR?

The FDA 510(k) record lists Foshan Care Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARE ZY5BA OXYGEN CONCENTRATOR?

The FDA product code for CARE ZY5BA OXYGEN CONCENTRATOR 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 Foshan Care Medical Technology Co., Ltd. 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.

K240840Oxygen Concentrator (ZY-10AB/115)K130001CARE SU01A SUCTION ASPIRATORK101552FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001

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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