INFUTEST 2000 INFUSION DEVICE ANALYZER— 510(k) K980165

Name: FDA 510(k) clearance K980165
Creator: U.S. Food and Drug Administration
Published: 1998-04-20

Substantially Equivalent

Datrend Systems, Inc.

FDA 510(k) clearance K980165 for INFUTEST 2000 INFUSION DEVICE ANALYZER, Substantially Equivalent on 1998-04-20. Applicant: Datrend Systems, Inc.. Device class: 2.

Clearance details

Applicant: Datrend Systems, Inc.
Product code: Code MRZ
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 1998-01-16
Decision date: 1998-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burnaby, British Columbia, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code MRZ

view all

K230718 — UTC 3mL Medication Cartridge2023-06-15
K220695 — Elite Biomedical Solutions Dose Request Cord2022-04-29
K201634 — RG 3ml Medication Cartridge2021-03-26
K193654 — BlueStar Rx2020-04-07
K191910 — SpaceStation MRI2020-03-12

More clearances from Datrend Systems, Inc.

view all

K062099 — PHASE 3, MODEL DT-12007-01-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.