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FDA 510(k)

MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC

K-Number: K012264 · 2001-10-10

ApplicantNational Custom Ent., Inc.
Decision Date2001-10-10
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC 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 2001-10-10 under 510(k) number K012264. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC?

MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC is a medical device that received FDA 510(k) clearance on 2001-10-10. The listed applicant is National Custom Ent., Inc.. The 510(k) number is K012264.

When did MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC receive FDA 510(k) clearance?

MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC received FDA 510(k) clearance on 2001-10-10, under 510(k) number K012264.

Who is the listed applicant for MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC?

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 MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC?

The FDA product code for MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC is DPS.

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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 N3024K012266SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2K012259MEDFUSION 2001 & 2010, MODEL N7215IWCK012262BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WCK012229SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WCK943680NCE REPLACEMENT BATTERIES

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Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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