FLYNN SERIES III BAG/MASK UNIT-— 510(k) K832495

Substantially Equivalent

O-Two Systems Intl., Inc.

FDA 510(k) clearance K832495 for FLYNN SERIES III BAG/MASK UNIT-, Substantially Equivalent on 1983-09-29. Applicant: O-Two Systems Intl., Inc..

Clearance details

Applicant: O-Two Systems Intl., Inc.
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 1983-07-27
Decision date: 1983-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code BTM

product code BTM

Death: 19
Other: 2
Total: 21

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.