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FDA 510(k)

MARK-5 CONCENTRATOR

K-Number: K883591 · 1988-11-02

ApplicantNidek Medical Products, Inc.
Decision Date1988-11-02
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MARK-5 CONCENTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Nidek Medical Products, Inc.. It received FDA 510(k) clearance on 1988-11-02 under 510(k) number K883591. 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 MARK-5 CONCENTRATOR?

MARK-5 CONCENTRATOR is a medical device that received FDA 510(k) clearance on 1988-11-02. The listed applicant is Nidek Medical Products, Inc.. The 510(k) number is K883591.

When did MARK-5 CONCENTRATOR receive FDA 510(k) clearance?

MARK-5 CONCENTRATOR received FDA 510(k) clearance on 1988-11-02, under 510(k) number K883591.

Who is the listed applicant for MARK-5 CONCENTRATOR?

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

What is the FDA product code for MARK-5 CONCENTRATOR?

The FDA product code for MARK-5 CONCENTRATOR is CAW.

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Other records listing Nidek Medical Products, 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.

K192693Nuvo Nano Portable Oxygen ConcentratorK123738MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STDK093308MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STDK082566MARK 5 NUVO LITE OCSI AND STDK040892MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905K032509MARK 5 NUVO (M5C5)

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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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