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FDA 510(k)

MEDFUSION 2001 & 2010, MODEL N7215IWC

K-Number: K012259 · 2001-09-12

ApplicantNational Custom Ent., Inc.
Decision Date2001-09-12
Product CodeMRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDFUSION 2001 & 2010, MODEL N7215IWC is the device name listed in this FDA 510(k) record. The listed applicant is National Custom Ent., Inc.. It received FDA 510(k) clearance on 2001-09-12 under 510(k) number K012259. The device is classified under product code MRZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDFUSION 2001 & 2010, MODEL N7215IWC?

MEDFUSION 2001 & 2010, MODEL N7215IWC is a medical device that received FDA 510(k) clearance on 2001-09-12. The listed applicant is National Custom Ent., Inc.. The 510(k) number is K012259.

When did MEDFUSION 2001 & 2010, MODEL N7215IWC receive FDA 510(k) clearance?

MEDFUSION 2001 & 2010, MODEL N7215IWC received FDA 510(k) clearance on 2001-09-12, under 510(k) number K012259.

Who is the listed applicant for MEDFUSION 2001 & 2010, MODEL N7215IWC?

The FDA 510(k) record lists National Custom Ent., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDFUSION 2001 & 2010, MODEL N7215IWC?

The FDA product code for MEDFUSION 2001 & 2010, MODEL N7215IWC is MRZ.

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Other records listing National Custom Ent., 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.

K012263MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024K012264MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWCK012266SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2K012262BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WCK012229SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WCK943632REPLACEMENT BATTERIES

View all 12 devices →

Related Devices (Code: MRZ)

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.

K230718UTC 3mL Medication CartridgeGilero, LLCK220695Elite Biomedical Solutions Dose Request CordElite Biomedical SolutionsK201634RG 3ml Medication CartridgeChengdu Shifeng Medical Technology Co., Ltd.K193654BlueStar RxWelldoc, Inc.K191910SpaceStation MRIB. Braun Melsugen AGK190013WellDoc BlueStarWelldoc, Inc.

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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