STA-SET I.V. FLOW REGULATOR— 510(k) K880006

Name: FDA 510(k) clearance K880006
Creator: U.S. Food and Drug Administration
Published: 1988-03-24

Substantially Equivalent

Controlled Flow , Ltd.

FDA 510(k) clearance K880006 for STA-SET I.V. FLOW REGULATOR, Substantially Equivalent on 1988-03-24. Applicant: Controlled Flow , Ltd.. Device class: 2.

Clearance details

Applicant: Controlled Flow , Ltd.
Product code: Code LDR
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 1988-01-04
Decision date: 1988-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stafford, TX, 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

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