AMBU OXYGEN REGULATOR— 510(k) K921125

Name: FDA 510(k) clearance K921125
Creator: U.S. Food and Drug Administration
Published: 1992-09-17

Substantially Equivalent

Amg, LLC

FDA 510(k) clearance K921125 for AMBU OXYGEN REGULATOR, Substantially Equivalent on 1992-09-17. Applicant: Amg, LLC. Device class: 1.

Clearance details

Applicant: Amg, LLC
Product code: Code CAN
Device class: Class 1
Regulation: 21 CFR 868.2700
Advisory panel: Anesthesiology
Date received: 1992-03-10
Decision date: 1992-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAN

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K162811 — MR Conditional CGA 8702017-03-02
K080243 — PORTABLE OXYGEN UNIT SCA9002009-04-07
K060265 — REMCORE REMOTE CONTROLLED OXYGEN REGULATOR2006-10-25
K061785 — CYL-FIL OXYGEN SYSTEM2006-09-07
K950777 — OXYGEN REGULATOR1995-04-14

Adverse events under product code CAN

product code CAN

Death: 4
Other: 1
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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