CYL-FIL OXYGEN SYSTEM— 510(k) K061785

Name: FDA 510(k) clearance K061785
Creator: U.S. Food and Drug Administration
Published: 2006-09-07

Substantially Equivalent

Responsive Respiratory, Inc.

FDA 510(k) clearance K061785 for CYL-FIL OXYGEN SYSTEM, Substantially Equivalent on 2006-09-07. Applicant: Responsive Respiratory, Inc.. Device class: 1.

Clearance details

Applicant: Responsive Respiratory, Inc.
Product code: Code CAN
Device class: Class 1
Regulation: 21 CFR 868.2700
Advisory panel: Anesthesiology
Date received: 2006-06-23
Decision date: 2006-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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K080243 — PORTABLE OXYGEN UNIT SCA9002009-04-07
K060265 — REMCORE REMOTE CONTROLLED OXYGEN REGULATOR2006-10-25
K950777 — OXYGEN REGULATOR1995-04-14
K942751 — VANGUARD SERIES GAS REGULATORS1995-02-09

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.