CYL-FIL OXYGEN SYSTEM— 510(k) K061785

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..

Clearance details

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

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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.