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FDA 510(k)

MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905

K-Number: K040892 · 2004-04-29

ApplicantNidek Medical Products, Inc.
Decision Date2004-04-29
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905 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 2004-04-29 under 510(k) number K040892. 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 NUVO OCSI (M5C5), MODELS 505 AND 905?

MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905 is a medical device that received FDA 510(k) clearance on 2004-04-29. The listed applicant is Nidek Medical Products, Inc.. The 510(k) number is K040892.

When did MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905 receive FDA 510(k) clearance?

MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905 received FDA 510(k) clearance on 2004-04-29, under 510(k) number K040892.

Who is the listed applicant for MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905?

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 NUVO OCSI (M5C5), MODELS 505 AND 905?

The FDA product code for MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905 is CAW.

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Other records listing Nidek Medical Products, Inc. as applicant

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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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