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510(k) K012259

MEDFUSION 2001 & 2010, MODEL N7215IWC by National Custom Ent., Inc. — Product Code MRZ

K012259 is an FDA 510(k) premarket notification submitted by National Custom Ent., Inc. for the device "MEDFUSION 2001 & 2010, MODEL N7215IWC". The FDA issued a decision of Substantially Equivalent on September 12, 2001. The device falls under product code MRZ (Accessories, Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. National Custom Ent., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2001
Date Received
July 18, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by National Custom Ent., Inc.

  • K012263 — MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024 (October 10, 2001)
  • K012264 — MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC (October 10, 2001)
  • K012262 — BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC (September 12, 2001)
  • K012266 — SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2 (September 12, 2001)
  • K012229 — SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C (September 10, 2001)
  • K943632 — REPLACEMENT BATTERIES (November 4, 1994)
  • K943680 — NCE REPLACEMENT BATTERIES (November 4, 1994)
  • K942629 — NCE REPLACEMENT BATTERIES (August 18, 1994)
  • K941995 — NCE REPLACEMENT BATTERIES (July 26, 1994)
  • K942244 — REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE (June 24, 1994)

Other clearances for product code MRZ

  • K230718 — UTC 3mL Medication Cartridge (June 15, 2023)
  • K220695 — Elite Biomedical Solutions Dose Request Cord (April 29, 2022)
  • K201634 — RG 3ml Medication Cartridge (March 26, 2021)
  • K193654 — BlueStar Rx (April 7, 2020)
  • K191910 — SpaceStation MRI (March 12, 2020)
  • K190013 — WellDoc BlueStar (November 4, 2019)
  • K173531 — Lockbox for Perfusor Space PCA Infusion Pump (August 2, 2018)
  • K171346 — Sapphire Sets (August 25, 2017)
  • K162532 — WellDoc BlueStar, WellDoc BlueStar Rx (January 12, 2017)
  • K160492 — Hospira Sapphire Sets (December 6, 2016)

FDA data resources