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510(k) K142374

ivWatch Model 400 by Ivwatch, LLC — Product Code MRZ

K142374 is an FDA 510(k) premarket notification submitted by Ivwatch, LLC for the device "ivWatch Model 400". The FDA issued a decision of Substantially Equivalent on February 13, 2015. The device falls under product code MRZ (Accessories, Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Ivwatch, LLC has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2015
Date Received
August 26, 2014
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 Ivwatch, LLC

  • K233881 — ivWatch® Model 400 (March 15, 2024)
  • K222212 — ivWatch Model 400 (August 24, 2022)
  • K192385 — ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Pati (July 2, 2020)
  • K162478 — ivWatch (December 22, 2016)
  • K153605 — ivWatch Model 400 (February 11, 2016)

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