OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830— 510(k) K010747

Name: FDA 510(k) clearance K010747
Creator: U.S. Food and Drug Administration
Published: 2001-05-16

Substantially Equivalent

Western Ent.

FDA 510(k) clearance K010747 for OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830, Substantially Equivalent on 2001-05-16. Applicant: Western Ent.. Device class: 2.

Clearance details

Applicant: Western Ent.
Product code: Code NFB
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 2001-03-13
Decision date: 2001-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westlake, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NFB

view all

K250322 — Respond OC Conserving Regulator (130-0800)2025-07-24
K220591 — Proxima2022-12-15
K221014 — Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile2022-10-17
K200401 — Apogee2020-11-14
K151506 — Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula2016-03-11

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