O_TWO CPAP SYSTEM— 510(k) K112546

Substantially Equivalent

O-Two Medical Technologies, Inc.

FDA 510(k) clearance K112546 for O_TWO CPAP SYSTEM, Substantially Equivalent on 2011-12-27. Applicant: O-Two Medical Technologies, Inc..

Clearance details

Applicant: O-Two Medical Technologies, Inc.
Product code: Code BYE
Advisory panel: Anesthesiology
Date received: 2011-09-01
Decision date: 2011-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code BYE

product code BYE

Death: 5
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.