Breathe Technologies Life2000 Ventilation System— 510(k) K170037

Substantially Equivalent

Breathe Technologies

FDA 510(k) clearance K170037 for Breathe Technologies Life2000 Ventilation System, Substantially Equivalent on 2017-08-11. Applicant: Breathe Technologies.

Clearance details

Applicant: Breathe Technologies
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 2017-01-04
Decision date: 2017-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

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.