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FDA 510(k)

A&J POCA01 OXYGEN CONCENTRATOR

K-Number: K071608 · 2008-01-11

ApplicantZhongshan A&J Medical Equipment Co., Ltd.
Decision Date2008-01-11
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

A&J POCA01 OXYGEN CONCENTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Zhongshan A&J Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2008-01-11 under 510(k) number K071608. 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 A&J POCA01 OXYGEN CONCENTRATOR?

A&J POCA01 OXYGEN CONCENTRATOR is a medical device that received FDA 510(k) clearance on 2008-01-11. The listed applicant is Zhongshan A&J Medical Equipment Co., Ltd.. The 510(k) number is K071608.

When did A&J POCA01 OXYGEN CONCENTRATOR receive FDA 510(k) clearance?

A&J POCA01 OXYGEN CONCENTRATOR received FDA 510(k) clearance on 2008-01-11, under 510(k) number K071608.

Who is the listed applicant for A&J POCA01 OXYGEN CONCENTRATOR?

The FDA 510(k) record lists Zhongshan A&J Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A&J POCA01 OXYGEN CONCENTRATOR?

The FDA product code for A&J POCA01 OXYGEN CONCENTRATOR is CAW.

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Other records listing Zhongshan A&J Medical Equipment 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.

K253340Electric Wheelchair (AL-208S-063)K121531A&J 5L POCA SERIES OXYGEN CONCENTRATORK071607ASA01 HEAVY DUTY SUCTION PUMP

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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