MODEL 2001 INTELLIGENT INFUSOR— 510(k) K834528

Name: FDA 510(k) clearance K834528
Creator: U.S. Food and Drug Administration
Published: 1984-02-21

Substantially Equivalent

Quest Medical, Inc.

FDA 510(k) clearance K834528 for MODEL 2001 INTELLIGENT INFUSOR, Substantially Equivalent on 1984-02-21. Applicant: Quest Medical, Inc.. Device class: 2.

Clearance details

Applicant: Quest Medical, Inc.
Product code: Code LDR
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 1983-12-21
Decision date: 1984-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LDR

view all

K242693 — DEKA Infusion System, DEKA Administration Set2024-10-07
K232316 — DEKA Infusion System, DEKA Administration Set2024-03-01
K153760 — Volumetric Infusion Controller2016-10-03
K963136 — PACER MODEL 100 INFUSION CONTROLLER1997-10-10
K971826 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/5001997-07-03

More clearances from Quest Medical, Inc.

view all

K241058 — Lyka® PORT Needle Free Access Device (4170Y)2024-12-18
K213846 — Q2 Blood Administration Sets2022-06-05
K213588 — Q2 IV Administration Sets2022-06-02
K202672 — Precision Delivery Infusion Set2021-01-21
K201984 — MPS 3 ND Myocardial Protection System2020-11-20

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