Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MARK 5 NUVO (M5C5)

K-Number: K032509 · 2004-03-18

ApplicantNidek Medical Products, Inc.
Decision Date2004-03-18
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MARK 5 NUVO (M5C5) 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 2004-03-18 under 510(k) number K032509. 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 (M5C5)?

MARK 5 NUVO (M5C5) is a medical device that received FDA 510(k) clearance on 2004-03-18. The listed applicant is Nidek Medical Products, Inc.. The 510(k) number is K032509.

When did MARK 5 NUVO (M5C5) receive FDA 510(k) clearance?

MARK 5 NUVO (M5C5) received FDA 510(k) clearance on 2004-03-18, under 510(k) number K032509.

Who is the listed applicant for MARK 5 NUVO (M5C5)?

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 (M5C5)?

The FDA product code for MARK 5 NUVO (M5C5) is CAW.

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 905K020797PULMO-MIST COMPRESSOR MODEL # 4323

View all 12 devices →

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.

↑