CAREVENT HANDHELD CPAP SYSTEM— 510(k) K093862

Substantially Equivalent

O-Two Medical Technologies, Inc.

FDA 510(k) clearance K093862 for CAREVENT HANDHELD CPAP SYSTEM, Substantially Equivalent on 2010-05-06. Applicant: O-Two Medical Technologies, Inc..

Clearance details

Applicant: O-Two Medical Technologies, Inc.
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 2009-12-17
Decision date: 2010-05-06
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.