ODYSSEY— 510(k) K922810

Substantially Equivalent

O-Two Systems Intl., Inc.

FDA 510(k) clearance K922810 for ODYSSEY, Substantially Equivalent on 1993-01-22. Applicant: O-Two Systems Intl., Inc..

Clearance details

Applicant: O-Two Systems Intl., Inc.
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 1992-06-10
Decision date: 1993-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

Download summary PDF View on FDA.gov ↗

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.