CAREVENT ATV+ AND CAREVENT MRI— 510(k) K051469

Substantially Equivalent

O-Two Medical Technologies, Inc.

FDA 510(k) clearance K051469 for CAREVENT ATV+ AND CAREVENT MRI, Substantially Equivalent on 2005-09-28. Applicant: O-Two Medical Technologies, Inc..

Clearance details

Applicant: O-Two Medical Technologies, Inc.
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 2005-06-03
Decision date: 2005-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

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.